Research and Clinical Trials

Title  
GOG 213: 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
Brief Description  
This 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 cancer, primary peritoneal cancer, or fallopian tube cancer.
Who may be Eligible  

  • Patients must have histologic diagnosis of ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or fallopian tube carcinoma
  • 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
    • 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

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 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
    • Uncontrolled hypertension
    • 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:
  • 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
IRB Number  
03-08-11B
Principal Investigator  
Higgins, Robert

For More Information, Contact  Sarah  , Norek
Phone:  (704) 355-1520  Fax:  (704) 355-1188  
Email:  sarah.norek@carolinashealthcare.org
Address:1025 Morehead Medical Drive Suite 600 Charlotte, NC 28204
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