Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

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Brief Title

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Official Title

GOG-0262: A Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination With Carboplatin With or Without Concurrent and Consolidation Bevacizumab (NSC #704865) in the Treatment of Primary Stage II, III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer and ACRIN 6695: Perfusion CT Imaging to Evaluate Treatment Response in Patients Participating in GOG-0262

Brief Summary

      This phase III clinical trial studies two different dose schedules of paclitaxel to see how
      well they work in combination with carboplatin with or without bevacizumab in treating
      patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or
      fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work
      in different ways to stop the growth of tumor cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called
      a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that
      tumors need to grow. It is not yet known whether giving paclitaxel with combination
      chemotherapy once every three weeks is more effective than giving paclitaxel once a week in
      treating patients with ovarian, primary peritoneal, or fallopian tube cancer.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine if the weekly paclitaxel regimen increases the time until first progression
      or death (progression-free survival [PFS]) compared to the every-3-week paclitaxel regimen in
      women with primary stage II, III or IV epithelial ovarian, peritoneal or fallopian tube
      cancer who are receiving carboplatin with or without bevacizumab.

      SECONDARY OBJECTIVES:

      I. To determine if the weekly paclitaxel increases the duration of overall survival compared
      to the every-3-week paclitaxel when combined with carboplatin with or without bevacizumab.

      II. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to the
      incidence of severe or serious adverse events when it is combined with carboplatin with or
      without bevacizumab.

      III. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to
      patients' self-reported quality of life (QOL) as measured by the Functional Assessment of
      Cancer Therapy-Ovarian (FACT-O)-Trial Outcome Index (TOI), when paclitaxel is combined with
      carboplatin with or without bevacizumab. (As of 02/08/2012, the QOL portion of this study is
      complete; patients enrolled after this date will not have QOL assessments)

      TRANSLATIONAL RESEARCH OBJECTIVES:

      I. To evaluate single nucleotide polymorphisms (SNPs) associated with progression-free
      survival and toxicity in advanced stage epithelial ovarian, peritoneal and fallopian tube
      cancer using genome wide association studies (GWAS).* II. To evaluate genomic signatures in
      tumor tissues which are predictive for patient survival in advanced stage epithelial ovarian,
      peritoneal and fallopian tube cancer.* III. To evaluate the association between serum and
      plasma biomarkers and response to anti-angiogenesis therapy in advanced stage epithelial
      ovarian, peritoneal, and fallopian tube cancer.*

      NOTE: *As of 02/08/2012, the translational research (TR) portion of this study is complete;
      patients enrolled after this date will not have TR specimens collected.

      IMAGING PRIMARY OBJECTIVES:

      I. To determine whether larger changes in the tumor perfusion parameters from baseline
      timepoint (T0) to early-therapy T2 are prognostic of higher progression-free survival (PFS)
      rate at 6 months (PFS-6) from enrollment in patients treated with weekly or every-3-week
      paclitaxel regimens, who are receiving carboplatin with or without bevacizumab.***

      IMAGING SECONDARY OBJECTIVES:

      I. To determine whether larger changes in tumor perfusion parameters from baseline T0 to
      intermediate T1 and from T1 to T2 are prognostic of higher PFS-6 in patients treated with
      weekly or every-3-week paclitaxel regimens, who are receiving carboplatin with or without
      bevacizumab.*** II. To determine whether larger changes in tumor perfusion parameters values
      from T0 to T1, T0 to T2, and T1 to T2 are prognostic of better overall survival in all
      treatment arms.*** III. To assess the association between changes in tumor perfusion
      parameters before and after chemotherapy initiation (T0 to T1) and subsequent best tumor
      response according to standard anatomic Response Evaluation Criteria in Solid Tumors
      (RECIST).*** IV. To assess the association between tumor perfusion parameters before
      chemotherapy and subsequent best tumor response according to RECIST, PFS-6, and overall
      survival.*** V. To test the assumption that tumor perfusion parameters are reliable,
      user-independent, and reproducible parameters of tumor microvascular characteristics; a
      subgroup of 15 patients will have repeat computed tomography (CT) perfusion studies at the
      intermediate T1 time point.***

      NOTE: ***Patients enrolled after February 8, 2012 must participate in the ACRIN 6695
      component at ACRIN-qualified institutions.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms (beginning on 04-30-2012, the trial
      is no longer randomized and the chemotherapy regimen is selected and declared prior to
      enrolling in the study).

      ARM I (adjuvant chemotherapy suboptimally debulked): Patients receive paclitaxel
      intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment
      repeats every 21 days for 6 courses.

      ARM II (neoadjuvant chemotherapy with interval cytoreductive surgery): Patients receive
      paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1.
      Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive
      surgery between courses 3 and 4.

      Patients in both arms may receive optional** bevacizumab IV over 30-90 minutes on day 1
      beginning in course 2. Courses of bevacizumab repeat every 21 days in the absence of disease
      progression or unacceptable toxicity. Patients in Arm II receive bevacizumab during courses
      2, 5, and 6 only.

      NOTE: **Before enrolling onto this study, each patient chooses whether the study treatment
      will include concurrent and maintenance bevacizumab.

      After completion of study treatment, patients are followed up every 3 months for 2 years,
      every 6 months for 3 years, and then annually thereafter.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Progression-Free Survival

Secondary Outcome

 Median Duration of First Quartile Survival

Condition

Fallopian Tube Endometrioid Adenocarcinoma

Intervention

Bevacizumab

Study Arms / Comparison Groups

 Arm I (adjuvant chemotherapy suboptimally debulked)
Description:  Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

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

Biological

Estimated Enrollment

692

Start Date

September 27, 2010


Primary Completion Date

December 1, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Primary Surgery and Neoadjuvant Chemotherapy with Interval Cytoreductive Surgery
             Patients:

          -  Patients must have measurable disease; at least one target lesion must have a minimum
             length of 1 cm in both the long and short axis (determined at the local site); for
             primary surgery patients, if no radiographic evidence of measurable disease is
             obtained prior to registration this can be based on surgical findings; imaging then
             would need to be completed in the 14 days between Gynecology Oncology Group (GOG)
             registration and chemotherapy initiation

               -  After GOG registration, the American College of Radiology [ACR] Imaging Core
                  Laboratory will confirm target lesion as required per protocol; the
                  GOG-eligibility (RECIST) scan and baseline T0 perfusion CT scans will be reviewed
                  prior to the intermediate T1 perfusion CT time point

          -  Primary Surgery Patients:

          -  Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary
             carcinoma or fallopian tube cancer, stage II -IV suboptimally debulked (any residual
             disease > 1 cm); International Federation of Gynecology and Obstetrics (FIGO) stage is
             assessed following the completion of initial abdominal surgery, appropriate imaging
             studies and with appropriate tissue available for histologic evaluation; the minimum
             surgery required is an abdominal surgery providing tissue for histologic evaluation
             and establishing and documenting the primary site and stage; if additional surgery was
             performed, it should have been in accordance with appropriate surgery for ovarian or
             peritoneal carcinoma described in the GOG Surgical Procedures Manual

          -  Neoadjuvant Chemotherapy (NAC) with Interval Cytoreductive Surgery (ICS) Patients:

          -  For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is
             required; the tissue must be consistent with a Müllerian origin; patients will require
             documentation of at least stage II or extraovarian sites of disease acquired via
             imaging or surgery (without attempt at cytoreduction)

          -  Patients with the following histologic epithelial cell types are eligible: serous,
             endometrioid, clear cell, mucinous adenocarcinoma, undifferentiated carcinoma, mixed
             epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or
             adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of
             the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma;
             patients may have co-existing fallopian tube carcinoma in-situ so long as the primary
             origin of invasive tumor is ovarian, peritoneal or fallopian tube; of note, patients
             with clear cell and mucinous tumors will be eligible unless there is a higher priority
             protocol

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot
             have been induced or supported by granulocyte colony stimulating factors

          -  Platelets greater than or equal to 100,000/mcl

          -  Creatinine =< 1.5 x institutional upper limit normal (ULN)

          -  Bilirubin less than or equal to 1.5 x ULN

          -  Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN

          -  Alkaline phosphatase less than or equal to 2.5 x ULN

          -  Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for
             Adverse Events (CTCAE) grade 1

          -  Patients must have a GOG performance status of 0, 1, or 2

          -  Patients must be entered within 12 weeks of diagnostic/staging surgery

          -  Patients who have met the pre-entry requirements

          -  An approved informed consent and authorization permitting release of personal health
             information and must be signed by the patient or guardian

          -  Only applies for patients who elect to receive bevacizumab:

               -  Patients in this trial may receive ovarian estrogen +/- progestin replacement
                  therapy as indicated at the lowest effective dose(s) for control of menopausal
                  symptoms at any time, but not high-dose progestins for management of anorexia
                  while on protocol-directed therapy or prior to disease progression due to
                  thrombophlebitis risk

               -  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 for management of venous thrombosis including pulmonary
                  thromboembolus) and a partial prothrombin time (PTT) < 1.2 times the upper limit
                  of normal; (heparin, lovenox or alternative anticoagulants are acceptable)

               -  All patients enrolled into GOG-0262 at sites where ACRIN 6695 is open will be
                  enrolled in the advanced imaging protocol; patients receiving adjuvant or
                  neoadjuvant chemotherapy are eligible for ACRIN 6695; the following sentence does
                  not apply to those patients entered after 02/08/2012: if a patient declines to
                  participate in the perfusion imaging portion of the protocol, a clinical
                  rationale for declination of imaging form will be completed as part of the data
                  submission for ACRIN 6695

          -  ACRIN 6695 Eligible Patients:

               -  Confirmation of ACRIN 6695 eligibility after the baseline T0 perfusion computed
                  tomography (CT) will be assessed by the ACR Imaging Core Lab: At least one target
                  lesion must have a minimum length of 1 cm in both the long and short axis (as
                  determined by the local site), at least half of the target lesion must have
                  attenuation greater than or equal to 10 Hounsfield Units (HU) on the unenhanced
                  CT, and at least half of the lesion must have maximum enhancement greater than or
                  equal to 5 HU in the perfusion CT scan (as determined by the ACR Imaging Core
                  Lab)

        Exclusion Criteria:

          -  Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly
             "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary
             peritoneal or fallopian tube cancer treated with surgery only (such as patients with
             stage I-A or I-B low grade epithelial ovarian or fallopian tube cancers) are not
             eligible; patients with a prior diagnosis of a borderline tumor that was surgically
             resected and who subsequently develop an unrelated, new invasive epithelial ovarian,
             peritoneal primary or fallopian tube cancer are eligible, provided that they have not
             received prior chemotherapy for any ovarian tumor

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis; prior radiation for localized cancer of the breast, head and neck, or skin
             is permitted, provided that it was completed more than three years prior to
             registration, and the patient remains free of recurrent or metastatic disease

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor
             including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian
             tube cancer; patients may have received prior adjuvant chemotherapy for localized
             breast cancer, provided that it was completed more than three years prior to
             registration, and that the patient remains free of recurrent or metastatic disease

          -  Patients who have received any targeted therapy (including but not limited to
             vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management
             of their epithelial ovarian, fallopian tube or peritoneal primary cancer

          -  Patients with synchronous primary endometrial cancer, or a past history of primary
             endometrial cancer, unless all of the following conditions are met: stage not greater
             than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular
             or lymphatic invasion; no poorly differentiated subtypes, including papillary serous,
             clear cell or other FIGO grade 3 lesions

          -  With the exception of non-melanoma skin cancer, patients with other invasive
             malignancies who had (or have) any evidence of the other cancer present within the
             last five years or whose previous cancer treatment contraindicates this protocol
             therapy

          -  Patients with acute hepatitis or active infection that requires parenteral antibiotics

          -  Patients with clinically significant cardiovascular disease; this includes:

               -  Myocardial infarction or unstable angina < 6 months prior to registration

               -  New York Heart Association (NYHA) grade II or greater congestive heart failure

               -  Serious cardiac arrhythmia requiring medication; this does not include
                  asymptomatic, atrial fibrillation with controlled ventricular rate

          -  Patients who are pregnant or nursing; patients of childbearing potential must agree to
             use contraceptive measures during study therapy and for at least six months after
             completion of bevacizumab therapy

          -  Patients who have received prior therapy with any anti-vascular endothelial growth
             factor (VEGF) drug, including bevacizumab

          -  Patients with medical history or conditions not otherwise previously specified which
             in the opinion of the investigator should exclude participation in this study; the
             investigator should feel free to consult the Statistical and Data Center (SDC)
             randomization desk for uncertainty in this regard

          -  Patients with known allergy to cremophor or polysorbate 80

          -  Only applies to patients who elect to receive bevacizumab:

          -  Patients with serious non-healing wound, ulcer, or bone fracture; this includes
             history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
             within 28 days; patients with granulating incisions healing by secondary intention
             with no evidence of fascial dehiscence or infection are eligible but require weekly
             wound examinations

          -  Patients with active bleeding or pathologic conditions that carry high risk of
             bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major
             vessels

          -  Patients with history or evidence upon physical examination of central nervous system
             (CNS) disease, including primary brain tumor, seizures not controlled with standard
             medical therapy, any brain metastases, or history of cerebrovascular accident (CVA,
             stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months
             of the first date of treatment on this study

               -  Patients with CTCAE grade 2 or greater peripheral vascular disease (at least
                  brief [< 24 hours] episodes of ischemia managed non-surgically and without
                  permanent deficit)

               -  Patients with a history of CVA within six months

          -  Patients with known hypersensitivity to Chinese hamster ovary cell products or other
             recombinant human or humanized antibodies

          -  Patients with clinically significant proteinuria; urine protein should be screened by
             urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly
             with the amount of protein excreted in a 24 hour urine collection; specifically, a
             UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine collection; obtain
             at least 4 ml of a random urine sample in a sterile container (does not have to be a
             24-hour urine); send sample to lab with request for urine protein and creatinine
             levels (separate requests); the lab will measure protein concentration (mg/dL) and
             creatinine concentration (mg/dL); the UPCR is derived as follows: protein
             concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow
             participation in the study

          -  Patients with or with anticipation of invasive procedures as defined below:

               -  Major surgical procedure, open biopsy or significant traumatic injury within 28
                  days prior to the first date of bevacizumab therapy (cycle 2)

               -  Major surgical procedure anticipated during the course of the study; this
                  includes, but is not limited to abdominal surgery (laparotomy or laparoscopy)
                  prior to disease progression such as colostomy or enterostomy reversal, secondary
                  cytoreductive surgery, or second look surgery; please consult with the SDC
                  Randomization Desk prior to patient entry for any questions related to the
                  classification of surgical procedures

               -  Any tissue biopsy, such as a core biopsy, within 7 days prior to the first date
                  of bevacizumab therapy (cycle 2)

          -  Patients with clinical symptoms or signs of gastrointestinal obstruction and who
             require parenteral hydration and/or nutrition

          -  Patients with metastasis tumor in the parenchyma of the liver or lungs with proximity
             to large vessels which could make the patients at high risk of lethal hemorrhage
             during treatment with bevacizumab (ie. hemoptysis, liver rupture)

          -  ACRIN 6695 Ineligible Patients:

               -  Patients with contraindication to iodinated contrast for perfusion CT imaging

               -  Patients who receive Metformin within 48 hours before perfusion CT imaging
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John K Chan, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01167712

Organization ID

NCI-2011-03812

Secondary IDs

NCI-2011-03812

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 NRG Oncology

Study Sponsor

John K Chan, Principal Investigator, NRG Oncology


Verification Date

May 2021