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Gynecologic Cancer

Carboplatin + Paclitaxel w/wo Bevacizumab After Surgery (GOG 213)
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination With Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreduction Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer
Status Conditions Phase Study ID
Recruiting Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Phase III GOG 213
NCT00565851
Summary

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.


Investigator
Benjamin E. Greer, MD
Location    
PSOC Office 206-667-5152  
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Group Health 206-225-7893  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Last Updated
March 01, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.