Brief Title
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
Official Title
Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Optional Postoperative Normothermic Intraperitoneal (IP) Chemotherapy to Treat Primary or Recurrent Carcinoma of Ovarian, Fallopian Tube, Uterine, or Peritoneal Origin
Brief Summary
This phase I trial studies the side effects and how well surgery and heated chemotherapy with
or without non-heated chemotherapy after surgery works in treating patients with ovarian,
fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy into the
abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or peritoneal
cancer may help lower the risk of the cancer coming back. Giving unheated chemotherapy drugs
directly into the abdomen after surgery may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVE:
I. To determine whether cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
(HIPEC) followed by postoperative normothermic intraperitoneal (IP) chemotherapy is feasible
and safe to administer, as measured by toxicities occurring during treatment or follow-up.
SECONDARY OBJECTIVES:
I. To determine quality of life (QoL) and compare the outcomes to a historical control of IP
chemotherapy (no HIPEC) for women with ovarian cancer.
II. To determine whether cytoreductive surgery with HIPEC alone is feasible and safe to
administer, as measured by toxicities occurring during treatment or follow-up.
III. To estimate progression-free survival (PFS). IV. To collect biospecimens and perform
correlative translational studies focused on understanding the mechanisms of action of HIPEC
on ovarian cancer.
OUTLINE:
Patients undergo surgery and receive hyperthermic cisplatin intraperitoneally (IP) over 60
minutes.
Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel,
pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or
intravenously (IV) at the discretion of the medical and gynecologic oncologists.
After completion of study treatment, patients are followed up at 3-6, 6-9, 9-12, and 12-15
months; every 3 months for 1 year; and then every 4 months for 1 year.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines
Secondary Outcome
Quality of life (QoL) assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QoL questionnaire
Condition
FIGO Stage IVA Ovarian Cancer
Intervention
Carboplatin
Study Arms / Comparison Groups
Treatment (surgery, HIPEC cisplatin)
Description: Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes. Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
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
40
Start Date
May 19, 2014
Completion Date
May 19, 2021
Primary Completion Date
May 19, 2021
Eligibility Criteria
Inclusion Criteria:
- Provided informed consent
- Patient with primary or recurrent International Federation of Gynecology and
Obstetrics (FIGO) stage III or IV, or recurrent ovarian, fallopian tube, peritoneal
carcinoma, or uterine cancer, confined to abdominal cavity, including those who have
completed neoadjuvant chemotherapy and primary surgery
- Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG)
performance status =< 1 or Karnofsky scale (KPS) >= 70%
- Patients who are platinum-sensitive or platinum resistant
- Candidate for potentially radical, maximal effort cytoreductive surgery at the
discretion and expertise of the treating physician
- For patients with newly diagnosed-ovarian/tubal/peritoneal cancer who have received
pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at
least one of the following:
- Decline in serum cancer antigen (CA) 125 level
- At least a 30% decrease in the sum of the longest diameter of target lesions on
radiographic imaging
- Improvement of ascites volume
- Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery
- Resolution of any effects of prior therapy (except alopecia and peripheral
neuropathy) to the current National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (NCI CTCAE) grade =< 1 and to baseline laboratory
values as defined
- Hemoglobin (HGB) >= 9 g/dL
- White blood cell (WBC) >= 3,000/mcL
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets (PLT) >= 100,000/mcL
- Total bilirubin within normal institutional limits
- Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase
(SGPT) < 2.5 x institutional upper limit of normal (ULN)
- Creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to
Cockcroft-Gault formula
- Neuropathy (sensory and motor) NCI CTCAE grade =< 2
- Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an
in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic
warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) <
1.2 times control
- Serum albumin >= 2.5
- No active infection requiring antibiotics
- Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal,
fallopian tubal or uterine cancer
- Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status
defined as no single lesion measuring more than 5.0 mm in its greatest diameter
- Stable from a cardiopulmonary standpoint to continue with prolonged surgery and
anesthesia
Exclusion Criteria:
- Patients with active extra-abdominal disease including active malignant pleural
effusion; patients who have been successfully treated with neoadjuvant chemotherapy
and no longer have (malignant) pleural effusions may be included
- Patients whose disease has progressed following at least 3 cycles of neoadjuvant
chemotherapy as defined by at least one of the following:
- Doubling of serum CA-125 level
- At least a 20% increase in the sum of the longest diameter of target lesions,
taking as reference the smallest sum longest diameter recorded since the
treatment started or the appearance of one or more new lesions
- Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel
obstruction, severe hypoalbuminemia, declining performance status)
- Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
- Patients whose circumstances do not permit completion of the study or the required
follow-up
- Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral
salpingo-oophorectomy
- Other active invasive malignancies, with the exception of non-melanoma skin cancer and
breast cancer (if without evidence of disease 1 year after completion of treatment)
- Metastatic non-gynecologic or breast primaries
- Sub-optimal resection as their surgical outcome
- Intraoperative frozen section suggesting hepatobiliary, pancreatic, adrenal, or
urinary tract cancer
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thanh Dellinger, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01970722
Organization ID
12316
Secondary IDs
NCI-2013-01948
Responsible Party
Sponsor
Study Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Thanh Dellinger, Principal Investigator, City of Hope Medical Center
Verification Date
August 2020