HIPEC After Initial CRS in Patients Who Have Received NACT

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Peritoneal Cancer HIPEC After Initial CRS in Patients Who Have Received NACT Study of Ramucirumab in Ovarian Cancer Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum Vaccine Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Capecitabine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC). 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Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Carboplatin With or Without Decitabine in Treating Patients With Progressive, Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Vaccine Therapy and OPT-821 or OPT-821 Alone in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer in Complete Remission Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Study of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD, Pembrolizumab, or Bevacizumab + Carboplatin in Adults With FRa + Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer AMG 706 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy ZD9331 With or Without Topotecan in Treating Patients With Refractory or Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Homologous Recombination Inquiry Through Ovarian Malignancy Investigations Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Trial of Best Supportive Care and Either Cisplatin or Paclitaxel to Treat Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer and Inoperable Malignant Bowel Obstruction Pegylated Liposomal Doxorubicin Hydrochloride, Carboplatin, Veliparib, and Bevacizumab in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Carboplatin, Gemcitabine Hydrochloride, and ATR Kinase Inhibitor VX-970 in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer PH3 Study of Mirvetuximab Soravtansine vs Investigator’s Choice of Chemotherapy in Women With FRa+ Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer A Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression 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Brief Title

HIPEC After Initial CRS in Patients Who Have Received NACT

Official Title

A Pilot Study of Heated Intraperitoneal Chemotherapy (HIPEC) After Interval Cytoreductive Surgery (CRS) in Patients Who Have Received Neoadjuvant Chemotherapy (NACT) for Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancers

Brief Summary

      The majority of women diagnosed with ovarian, fallopian tube and primary peritoneal cancer
      present with advanced stage III and IV disease. Despite aggressive surgery and systemic
      chemotherapy, the majority of patients will relapse. Five year survival remains only 20-35%
      for patients diagnosed with bulky stage IIIC and IV cancers. Patients who are not candidates
      for an initial cytoreductive surgery at the time of diagnosis form a particularly poor
      prognosis group. These patients are treated with neoadjuvant chemotherapy (NACT) and will
      ultimately undergo cytoreductive surgery provided there is a response to chemotherapy. New
      therapies for this cohort of women are urgently needed.

      The investigators have designed a pilot study to evaluate the feasibility of heated
      intraoperative peritoneal chemotherapy (HIPEC) given at the time of interval cytoreductive
      surgery after 3 cycles of NACT. Patients undergoing NACT for ovarian, fallopian tube or
      primary peritoneal cancer will be evaluated after their third cycle of chemotherapy for trial
      participation. Patient meeting eligibility criteria will proceed with cytoreductive surgery.
      HIPEC will be administered in those patients in whom optimal tumor cytoreduction is achieved.
      Primary objective of this study is to evaluate the feasibility, toxicity and tolerability of
      HIPEC administered after NACT.
    

Detailed Description

      Cancer of the ovary, fallopian tube and peritoneum (referred to as epithelial ovarian cancer,
      EOC) remains the leading cause of death from gynecologic cancer in the US and is expected to
      account for 22,000 cases and 14,000 deaths in 2016. Patients classically present with
      peritoneal carcinomatosis and ascites, a reflection of the dissemination pattern of this
      cancer in the peritoneal cavity. Malignant cells in EOC disseminate throughout the peritoneal
      cavity forming tumors on the parietal and visceral peritoneum. The majority of patients will
      be found to have advanced International Federation of Gynecology and Obstetrics (FIGO) stage
      III and IV disease at initial presentation. Patients with peritoneal carcinomatosis from EOC
      most often succumb to advanced locoregional disease in the form of intractable ascites,
      malignant visceral obstruction and cancer cachexia.

      Primary cytoreductive surgery (PCS) followed by systemic chemotherapy has been the standard
      of care for women presenting with advanced EOC. The ability to achieve optimal surgical
      cytoreduction is historically the most important prognostic factor for women with EOC. The
      Gynecologic Oncology Group defines optimal cytoreduction as a post-operative residual disease
      of ≤ 1 cm in largest diameter . Wide variability in the extent and effort of cytoreductive
      surgery is seen in clinical practice with surgical cytoreductive efforts ranging from
      standard procedures (hysterectomy, salpingo-opherectomy, omentectomy) to complex multiviceral
      resections that may require radical upper abdominal surgery. There is increasing evidence
      that the patients who ultimately gain the most benefit from surgery are those with no gross
      residual disease (R0 resection) at the completion of PCS . An examination of 2,655 patients
      with epithelial ovarian cancer or primary peritoneal cancer enrolled in the Gynecologic
      Oncology Group 182 study demonstrated improved OS and PFS in those patients with in whom PCS
      resulted in a complete gross resection . Patients presenting with bulky upper abdominal
      disease (UAD) have a particularly poor prognosis. Women presenting with bulky UAD have been
      shown to have inferior PFS and OS survival compared to patents with no or limited UAD even
      among patients in whom optimal debulking surgery is successfully performed . Importantly, the
      presence of bulky UAD is associated with diminishing rates of successful PCS.

      Advanced stage EOC is heterogenous, ranging from limited intra-abdominal disease to diffuse
      carcinomatosis involving the majority of the peritoneal surfaces. Use of a universal staging
      system for peritoneal malignancy may aid the clinician in treatment planning and
      prognostication. While several attempts have been made to develop peritoneal cancer scoring
      systems, the most widely used is the Peritoneal Cancer Index (PCI) as described by Jacquet
      and Sugarbaker in 1996 . The PCI quantitates the volume of tumor implants in 13 different
      abdomino-pelvic regions which are added up to form a score ranging from 0-39. While the PCI
      may be used as a prognostic indicator, it does not directly correlate with resectability of
      the disease. Tumor involvement of critical anatomic sites, for example regions 9, 10 and 11,
      representing the jejunum and ileum, may be associated with unresectable disease despite a low
      PCI score .

      Two recently published randomized controlled trials demonstrated that neoadjuvant
      chemotherapy (NACT) and interval cytoreductive surgery (ICS) was non-inferior to PCS and
      adjuvant chemotherapy and resulted in a lower incidence of treatment related morbidity and
      mortality. These trials, however, have been criticized for lower optimal debulking rates and
      significantly lower median overall survival rates compared to prior trials in advanced EOC.
      The choice between PCS and NACT remains controversial and clinical guidelines have recently
      been published to aid clinicians in the choice between these treatment plans .

      Patients who are not candidates for PCS due to medical comorbidities, poor performance status
      or clinically apparent or obvious unresectable disease constitute a group with a particularly
      poor prognosis. These patients are preferentially treated with neoadjuvant chemotherapy
      (NACT). NACT is associated with decreased peri-operative morbidity and an increased
      likelihood of optimal cytoreduction at surgery compared with primary surgery, however, to
      date a survival benefit or improvement has not been demonstrated . A recent
      multi-institutional observational study evaluating the use of NACT in patients with stage
      III/IV EOC at 6 NCI designated cancer centers demonstrated a significant increase in the use
      of NACT since 2010, from 16 - 34% in stage III and from 41 - 62% in stage IV EOC . Patients
      who received NACT were more likely to undergo optimal CRS but were less likely to require ICU
      admission or re-hospitalization. Among women with stage IIIC disease who had optimal CRS to
      ≤1 cm, NACT was associated with decreased overall survival when compared to PCS. This
      difference in survival, however, did not persist in NACT patients in whom CRS resulted in no
      gross residual disease.

      Because of the tendency for EOC to remain confined within the peritoneal cavity for much of
      the course of disease, the use of post-operative intra-peritoneal (IP) chemotherapy has been
      extensively evaluated in women who have undergone successful cytoreductive surgery (CRS).
      Four large randomized clinical trials have been performed by the Gynecologic Oncology Group
      (GOG), three of which demonstrate improved overall survival in patients treated with an IP
      regimen. GOG 172 demonstrated a striking 16 month improvement in overall survival in
      patient's receiving IP cisplatin and paclitaxel when compared to patients receiving
      intravenous cisplatin and paclitaxel, a survival difference that was sustained in a follow-up
      publication after a median 10 year survival . Despite randomized controlled trial (RCT)
      evidence supporting a survival advantage for IP chemotherapy, its use remains low, largely
      due to potential toxicity and possible IP catheter complications. Despite optimal CRS and
      systemic chemotherapy the majority of patients will ultimately experience recurrence of the
      disease.

      Heated intra-operative peritoneal chemotherapy (HIPEC) has garnered interest in the
      international oncology community for the treatment of peritoneal surface malignancies. HIPEC
      has demonstrated clinical efficacy for the treatment of pseudomyxoma peritonei, appendiceal
      cancer, colon cancer and malignant mesothelioma. HIPEC allows for the treatment of residual
      microscopic disease at the completion of CRS. HIPEC takes advantage of the plasma-peritoneal
      barrier to allow for peritoneal drug levels 20-1000 times that seen in plasma . HIPEC to
      >41°C may have anti-tumor effects as well as allow for better penetration of the drug into
      residual tumor . The use of HIPEC at the time of surgery, prior to the formation of
      adhesions, may allow for improved distribution of chemotherapy throughout the peritoneal
      cavity.

      HIPEC has been investigated as a treatment for patients with newly diagnosed EOC as well as
      for patients with recurrent disease. Retrospective and case-control studies show a survival
      advantage for patients in both the primary and recurrent disease setting.

      A recent randomized controlled study performed in Europe was the first well-designed,
      randomized, prospective clinical trial to demonstrate a survival advantage for HIPEC in EOC .
      This phase 3 randomized trial evaluated the administration of HIPEC using cisplatin in women
      undergoing interval cytoreductive surgery after NACT and demonstrated a significant
      improvement in progression free and overall survival with acceptable toxicity.

      By far, the most common drug evaluated in HIPEC for EOC is Cisplatin. Cisplatin (CDDP) is a
      heavy metal complex containing a central atom of platinum surrounded by two chloride atoms
      and two ammonia molecules in the cis- position. It has biochemical properties similar to that
      of bifunctional alkylating agents producing inter- and intra-strand cross-links in DNA. It is
      non-cell-cycle specific. Approximately 95% of the dose is absorbed from the peritoneal cavity
      in 1.0 hour. CDDP concentrates in the liver, kidney and intestine and is excreted by the
      kidneys. The dose of CDDP recommended for normothermic intraperitoneal administration is the
      same as that recommended for intravenous administration and ranges from 75 -100 mg/m2. The
      major dose-limiting toxicity of CDDP is dose-related cumulative renal insufficiency. Other
      toxicities include ototoxicity, myelosuppression, nausea and vomiting, hair loss and
      peripheral neuropathy.

      A recent phase I multicenter trial of NACT followed by HIPEC in EOC using CDDP established a
      dose of 70 mg/m2 as a tolerable dose in patients who had received 6 cycles of carboplatin and
      paclitaxel neoadjuvant chemotherapy . The results of this recently published phase I clinical
      trial are encouraging. However, in current clinical practice, patients tend to receive 3
      cycles of NACT with carboplatin and paclitaxel based regimens followed by CRS, as opposed to
      6 initial cycles of NACT given in the phase I study.

      The investigators propose a pilot study evaluating the feasibility of HIPEC in women
      undergoing interval CRS and achieving optimal tumor cytoreduction after 3 cycles of NACT. The
      safety, tolerability and efficacy of HIPEC will be evaluated in this cohort of EOC patients
      with historically inferior outcomes.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Morbidity, assessed by the occurrence of adverse events and serious adverse events

Secondary Outcome

 Progression-free survival

Condition

Ovarian Cancer

Intervention

Cisplatin

Study Arms / Comparison Groups

 HIPEC
Description:  Patient will receive HIPEC in the form of Cisplatin 100mg/m2. 5. HIPEC will be provided at completion of surgical cytoreduction. The chemotherapy will be ordered by the treating gynecologic oncologist. It will be prepared in the chemotherapy pharmacy and delivered to the operating room once the surgeon confirms optimal cytoreduction and eligibility. Patients undergoing bowel resection will be left with bowel in discontinuity during the HIPEC infusion cycle. The abdomen will be temporarily closed with skin staples to prevent spillage of the perfusate. HIPEC will be delivered using the closed technique as has been well described.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

15

Start Date

March 12, 2019

Completion Date

July 1, 2024

Primary Completion Date

July 5, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Histologically confirmed cancer of the ovary, fallopian tube or peritoneum.

          2. Women of all races and ethnicities are eligible for this trial.

          3. Age > 18.

          4. The patient must have documented disease limited to the abdomen and pelvis that is
             amenable to complete CRS indicated by:

               1. Disease confined to the peritoneal surfaces.

               2. No clinical or radiological evidence of hematogenous or distant (extra-abdominal)
                  nodal metastasis.

          5. Evidence of response to NACT must as documented by at least one of the following:
             decline in serum CA125 level, at least a 30% decrease in the sum of the longest
             diameter of target lesions on radiographic imaging, or resolution of ascites or
             pleural effusion(s).

          6. Gynecologic Oncology Group (GOG) performance status <= 2

          7. Leukocytes >= 3,000/microliter (mcL), absolute neutrophil count >= 1,500/mcL,
             platelets >= 100,000/mcL

          8. Adequate hepatic function as measured by total bilirubin within normal institutional
             limits, aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             (SGOT))/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT))
             =< 2.5 x institutional upper limit of normal

          9. Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for
             patients with creatinine levels above institutional normal

         10. Albumin >= 2.5 mg/dL

         11. Satisfactory cardiopulmonary function (no history of severe congestive heart failure
             or severe pulmonary disease, as indicated by clinically acceptable risks to undergo
             major abdominal surgery

         12. Voluntary participation after getting written informed consent

        Exclusion Criteria:

          1. Prior chemotherapy (other than NACT) or whole abdomen radiation for ovarian, fallopian
             tube or primary peritoneal cancers.

          2. Patients with an active second malignancy regardless of site.

          3. Uncontrolled inter-current illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          4. Pregnant or breast-feeding patients

          5. Patients who are receiving other oncologic investigational therapeutic agents

          6. Patients receiving NACT whose disease has progressed following at least 3 cycles of
             platinum-based therapy, defined by at least one of the following: clinical
             deterioration (new or worsening of existing ascites, carcinomatous ileus, malignant
             bowel obstruction, declining performance status); new lesion(s) or increase in maximal
             diameter of > 20% of the two largest target lesions; rising CA-125 (an increase of at
             least 10% of baseline value that increases over 3 values obtained every 21 days).

          7. Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery.

          8. Patients found to have non-gynecologic cancer at the time of surgery.

          9. Patients with gynecologic malignancy of low-grade serous or borderline histology.
      

Gender

Female

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Jill Whyte, MD, 5165624438, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03540017

Organization ID

IRB #: 18-0153


Responsible Party

Principal Investigator

Study Sponsor

Northwell Health

Collaborators

 Katie Oppo Research Fund

Study Sponsor

Jill Whyte, MD, Principal Investigator, Northwell Health


Verification Date

March 2020