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Therapeutic Areas: Oncology
Disease Category: Fallopian Tube Cancer

Trial Information

Carboplatin and Paclitaxel With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying giving carboplatin and paclitaxel together with or without bevacizumab after surgery to see how well it works in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.

DISEASE CHARACTERISTICS:

• Patients must have histologic diagnosis of ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or fallopian tube carcinoma
• Recurrent disease* NOTE: *Patients with biochemical recurrence, by definition, are not eligible for surgical randomization and should be considered for the chemotherapy randomization alone.
• The following histologic epithelial cell types** are allowed:
  • Serous adenocarcinoma
  • Endometrioid adenocarcinoma
  • Mucinous adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
  • Mixed epithelial carcinoma
  • Transitional cell carcinoma
  • Malignant Brenner Tumor
  • Adenocarcinoma not otherwise specified NOTE: **Prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and subsequently developed an unrelated, new invasive ovarian epithelial or primary peritoneal cavity cancer allowed provided the histological criteria for epithelial cell type is met
• 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 I-B
  • No more than superficial myometrial invasion
  • No vascular or lymphatic invasion
  • No poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
  • Patients must have had a complete response to front-line platinum-taxane therapy (at least 3 cycles) and a treatment-free interval without clinical evidence of progressive disease lasting at least 6 months
• Front-line therapy may have included a biologic agent (e.g., bevacizumab) but an interval of at least 6 months must have elapsed after completion of therapy
• A complete response to front-line chemotherapy must include the following:
  • Negative physical exam
  • Negative pelvic exam
  • Normalization of CA125, if elevated at baseline
  • Negative radiographic assessment of disease
  • Front-line treatment may include maintenance therapy following complete clinical or pathological response provided recurrent disease is not identified earlier than 6 months following completion of all anticancer treatment
• Patients receiving maintenance biological therapy or hormonal therapy are eligible provided their recurrence is documented more than 6 months from primary cytotoxic chemotherapy completion (includes maintenance chemotherapy) AND a minimum of 4 weeks has elapsed since their last infusion of biological therapy
• Patients enrolled on GOG-0198 or patients receiving hormonal therapy for biochemical or non-measurable recurrence disease are eligible provided their recurrence is documented more than 6 months following the completion of primary cytotoxic chemotherapy AND a minimum of 4 weeks must have elapsed since their last exposure to hormonal therapy
• Clinically evident measurable or nonmeasurable disease*** defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
• Each lesion must be = 20 mm when measured by conventional techniques, MRI or CT scan, or = 10 mm when measured by spiral CT scan
• Nonmeasurable disease defined by symptomatic ascites or pleural effusion
• Patients with clinically evident measurable or nonmeasurable disease must also have any 1 of the following:
  • CA-125 > 2 times upper limit of normal
  • Histologic confirmation of recurrence in the absence of an elevated CA-125 and measurable disease NOTE: ***Patients with nonmeasurable, clinically-evident disease, by definition, are not eligible for surgical randomization and should be considered for the chemotherapy randomization alone.

PATIENT CHARACTERISTICS:
Inclusion criteria:

• GOG performance status of 0, 1, or 2
• Platelet count ≥ 100,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Creatinine ≤ 1.5 mg/dL (133 < mol/L) OR creatinine clearance ≥ 60 mL/min
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT/AST and alkaline phosphatase ≤ 2.5 times ULN (< 5.0 times ULN in the presence of liver metastasis)
• Urine protein-to-creatinine ratio < 1.0 mg/dL
• Signed an approved informed consent and authorization permitting release of personal health information
• Patients with allergic (i.e., hypersensitivity) reactions to these chemotherapeutic agents are eligible if they were successfully retreated following a desensitization program or protocol

Patient Exclusion Criteria:

• Patients who require parenteral hydration or nutrition and have evidence of partial bowel obstruction or perforation
• Patients with uncontrolled infection
• Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
• Patients with peripheral neuropathy ≥= grade 2
• Patients with a history of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds
• Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
• Patients of childbearing potential not practicing adequate contraception or patients who are pregnant or nursing
• Patients with other invasive malignancies, with the exception of nonmelanoma skin cancer, or patients who had (or have) any evidence of the other cancer present within the past 5 years or whose previous cancer treatment contraindicates this protocol therapy
• Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major vessels
• Patients with a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or a history of stroke within the past 5 years
• Patients with clinically significant cardiovascular disease including any of the following:
  • Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or 2nd or 3rd degree atrioventricular block)
  • Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg
  • Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months
  • New York Heart Association grade II or greater congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Grade II or greater peripheral vascular disease unless (<24 hrs) episodes of ischemia managed non-surgically and without permanent deficit
  • History of cerebrovascular accident within the past 6 months
  • No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior adjuvant chemotherapy for localized breast cancer unless it was completed more than 5 years ago and the patient remains free of recurrent or metastatic disease
• No more than 1 prior regimen of chemotherapy (maintenance therapy is not considered a second regimen)
• No prior radiotherapy to any portion of the abdominal cavity or pelvis
• No prior chemotherapy for any other abdominal or pelvic tumor other than ovarian, fallopian tube, or primary peritoneal cancer
• No major surgical procedure, open biopsy, or dental extractions or other dental surgery/procedure that results in an open wound within the past 28 days
• No placement of vascular access device or core biopsy within the past 7 days
• No concurrent immunotherapy or radiotherapy
• No anticipation of need for major surgical procedure during the course of the study

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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