Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Condition: Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube Mucinous Adenocarcinoma; Fallopian Tube Serous Adenocarcinoma; Fallopian Tube Transitional Cell Carcinoma; Fallopian Tube Undifferentiated Carcinoma; Malignant Ovarian Brenner Tumor; Ovarian Clear Cell Adenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Adenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Serous Adenocarcinoma; Ovarian Transitional Cell Carcinoma; Ovarian Undifferentiated Carcinoma; Primary Peritoneal Clear Cell Adenocarcinoma; Primary Peritoneal Endometrioid Adenocarcinoma; Primary Peritoneal Serous Adenocarcinoma; Primary Peritoneal Transitional Cell Carcinoma; Primary Peritoneal Undifferentiated Carcinoma; Stage II Fallopian Tube Cancer AJCC v6 and v7; Stage II Ovarian Cancer AJCC v6 and v7; 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 III Ovarian Cancer AJCC v6 and v7; Stage III Primary Peritoneal Cancer AJCC v7; Stage IIIA Ovarian Cancer AJCC v6 and v7; Stage IIIA Primary Peritoneal Cancer AJCC v7; Stage IIIB Ovarian Cancer AJCC v6 and v7; Stage IIIB Primary Peritoneal 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, Clear Cell; Adenocarcinoma, Mucinous; Cystadenocarcinoma; Brenner Tumor
Intervention: Bevacizumab; Carboplatin; Carboplatin; Cisplatin; Laboratory Biomarker Analysis; Paclitaxel; Paclitaxel; Quality-of-Life Assessment
Intervention description: Given IV; Given IV; Given IP; Given IP; Correlative studies; Given IV; Given IP; Ancillary studies
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Bevacizumab; Cisplatin; Carboplatin; Antineoplastic Agents, Immunological; Endothelial Growth Factors; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Immunoglobulin G
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1560.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies bevacizumab and intravenous (given into a vein)
      chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (given
      into the abdominal cavity) chemotherapy in treating patients with stage II-III ovarian
      epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal
      antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread by
      blocking the growth of new blood vessels necessary for tumor growth. Drugs used in
      chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing. It
      is not yet known whether giving bevacizumab together with intravenous chemotherapy is more
      effective than giving bevacizumab together with intraperitoneal chemotherapy in treating
      patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary
             peritoneal carcinoma, stage II, III, or IV with either optimal (=< 1 cm residual
             disease) or suboptimal residual disease; in the event of a higher priority Phase III
             Gynecologic Oncology Group (GOG) protocol becoming available for suboptimal and/or
             stage IV patients, the eligibility of this study will narrow and exclude those
             patients at those participating institutions (11/02/2009)

               -  Note: patients with suboptimal disease/and or stage IV will not be eligible as of
                  April 1, 2011; they should be enrolled on GOG-0262 (03/14/11)

               -  All patients must have a procedure for determining diagnosis of epithelial
                  ovarian, fallopian tube, primary peritoneal, with appropriate tissue 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, as well as a maximal effort at tumor debulking; 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 (https://www.gog.fccc.edu/manuals/pdf/surgman.pdf)
                  (11/02/2009)(08/16/2010)

          -  Patients with the following histologic epithelial cell types are eligible: serous
             adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated
             carcinoma, clear cell adenocarcinoma, 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; if doubt exists, it is recommended that
             the investigator should have the slides reviewed by an independent pathologist prior
             to entry; patients may have co-existing endometrial cancer so long as the primary
             origin of invasive tumor is ovarian or peritoneal; Note: patients with mucinous, low
             grade and clear cell disease are eligible unless there is a higher priority GOG trial
             open (11/02/2009) (08/16/2010)

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to
             Common Terminology Criteria for Adverse Events v3.0 (CTCAE) grade 1; this ANC cannot
             have been induced or supported by granulocyte colony stimulating factors

          -  Platelets greater than or equal to 100,000/mcl

          -  Creatinine no greater than institutional upper limits of normal (03/29/10)

          -  Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)

          -  Alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than or equal to
             2.5 x ULN (CTCAE grade 1)

          -  Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)

          -  Neuropathy (sensory and motor) less than or equal to CTCAE grade 1

          -  Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN
             (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of
             therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 times the upper
             limit of normal (heparin, Lovenox or alternative anticoagulants are acceptable); this
             corresponds to CTCAE version 3.0 grade 1 one or less (11/02/2009) (03/29/10)

          -  Patients with a GOG performance status of 0, 1, or 2

          -  Patients must be entered and treated within 12 weeks of their most recent surgery
             performed for the combined purpose of diagnosis, staging and/or cytoreduction; the
             first cycle of chemotherapy should not be given until at least seven days after the
             most recent major surgery, which allows 4 weeks to have elapsed prior to the first
             bevacizumab dose; (placement of venous or peritoneal access devices will be considered
             minor surgery) (03/29/10)

          -  Patients who have met the pre-entry requirements specified

          -  An approved informed consent and authorization permitting release of personal health
             information must be signed by the patient or guardian

          -  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 high dose progestin as an appetite stimulant should be avoided (03/29/10)

        Exclusion Criteria:

          -  Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly
             "tumors of low malignant potential") or recurrent invasive epithelial ovarian cancer
             treated with surgery only (such as those with stage IA or IB low grade lesions) 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 or peritoneal primary cancer are eligible, provided that they have not
             received prior chemotherapy for any ovarian tumor

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer and other specific malignancies are excluded if there is any
             evidence of the other malignancy being present within the last five years; patients
             are also excluded if their previous cancer treatment contraindicates this protocol
             therapy (11/02/2009)

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis are excluded; 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 or primary peritoneal cancer are
             excluded; 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 or peritoneal primary cancer

          -  Patients with synchronous primary endometrial cancer, or a past history of primary
             endometrial cancer, are excluded, unless all of the following conditions are met:
             stage not greater than IB; 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

          -  Patients with acute hepatitis or active infection that requires parenteral antibiotics

          -  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 major central nervous
             system (CNS) disease (for example: primary brain tumor, metastatic cancer in the
             brain, 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) (11/02/2009) (03/29/10)

          -  Patients with clinically significant cardiovascular disease; this includes:

               -  Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mmHg

               -  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, or past
                  history of supraventricular tachycardia controlled with medications and that is
                  asymptomatic (03/29/10)

               -  CTCAE grade 2 or greater peripheral vascular disease (at least brief (< 24 hrs)
                  episodes of ischemia managed non-surgically and without permanent deficit)

          -  Patients with known hypersensitivity to Chinese hamster ovary cell products or other
             recombinant human or humanized antibodies; patients with known allergy to Cremophor or
             polysorbate 80

          -  Patients with clinically significant proteinuria; urine protein should be screened by
             urine protein-creatinine ratio (UPCR); 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, interval
                  or secondary cytoreductive surgery, or second look surgery

               -  Core biopsy, within 7 days prior to the first date of bevacizumab therapy (cycle
                  2)

          -  Patients with GOG performance grade of 3 or 4

          -  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 clinical symptoms or signs of gastrointestinal obstruction and/ or those
             who require parenteral hydration and/or nutrition; patients with history or current
             diagnosis of inflammatory bowel disease are not eligible (12/20/10)

          -  Patients with medical history or conditions not otherwise previously specified which
             in the opinion of the investigator should exclude participation in this study;
             examples of this would be: persistent gastrointestinal symptoms resulting from
             clostridia difficile enterocolitis or bowel surgery which may increase
             gastrointestinal toxicity from bevacizumab; or hearing loss or neuropathy which would
             prevent tolerance to cisplatin, and paclitaxel administration; the investigator should
             feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard
             (12/20/10)

          -  Patients with metastatic tumor in the parenchyma of the liver or lungs with proximity
             to large vessels which could make the patient as high risk of lethal hemorrhage during
             treatment with bevacizumab (i.e. hemoptysis, liver rupture) (11/02/2009)