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
Condition: Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube Mucinous Adenocarcinoma; Fallopian Tube Transitional Cell Carcinoma; Ovarian Brenner Tumor; Ovarian Clear Cell Adenocarcinofibroma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Adenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Serous Adenocarcinoma; Ovarian Transitional Cell Carcinoma; Ovarian Undifferentiated Carcinoma; Primary Peritoneal Serous Adenocarcinoma; Stage IIA Fallopian Tube Cancer AJCC v6 and v7; Stage IIA Ovarian Cancer AJCC V6 and v7; Stage IIB Fallopian Tube Cancer AJCC v6 and v7; Stage IIB Ovarian Cancer AJCC v6 and v7; Stage IIC Fallopian Tube Cancer AJCC v6 and v7; Stage IIC Ovarian Cancer AJCC v6 and v7; Stage IIIA Fallopian Tube Cancer AJCC v7; Stage IIIA Ovarian Cancer AJCC v6 and v7; Stage IIIA Primary Peritoneal Cancer AJCC v7; Stage IIIB Fallopian Tube Cancer AJCC v7; Stage IIIB Ovarian Cancer AJCC v6 and v7; Stage IIIB Primary Peritoneal Cancer AJCC v7; Stage IIIC Fallopian Tube Cancer AJCC v7; Stage IIIC Ovarian Cancer AJCC v6 and v7; Stage IIIC Primary Peritoneal Cancer AJCC v7; Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IV Ovarian Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7
MeSH terms: Carcinoma; Adenocarcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Transitional Cell; Cystadenocarcinoma, Serous; Carcinoma, Endometrioid; Adenocarcinoma, Mucinous; Cystadenocarcinoma; Brenner Tumor
Intervention: Bevacizumab; Carboplatin; Computed Tomography; Paclitaxel; Therapeutic Conventional Surgery
Intervention description: Given IV; Given IV; Correlative studies; Given IV; Undergo surgery
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Albumin-Bound Paclitaxel; Antineoplastic Agents, Immunological; Endothelial Growth Factors; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Immunoglobulin G
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 692.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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