Research and Clinical Trials

Title  
GOG 0212: A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or (CT-2103) (IND#70177) versus no Treatment Until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal Cancer
Brief Description  
This trial is studying paclitaxel to see how well it works compared to observation only in patients with stage III or stage IV ovarian or peritoneal cancer.
Who may be Eligible  

  • Histologically confirmed ovarian epithelial or primary peritoneal cancer
    • Stage III or IV disease
  • 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
  • The following histologic cell types are not allowed:
    • Germ cell tumor
    • Sex cord-stromal tumor
    • Carcinosarcoma
    • Mixed müllerian tumor or carcinosarcoma
    • Metastatic carcinoma from other sites to the ovary
    • Low malignant potential (LMP) tumor (borderline carcinoma), including micropapillary serous carcinoma
      • Patients with a prior diagnosis of LMP tumor that was surgically resected and who subsequently developed invasive adenocarcinoma are eligible provided patient did not receive prior chemotherapy for the ovarian LMP tumor
  • Must have undergone surgery for ovarian epithelial or primary peritoneal cancer AND have tissue available for histologic evaluation
  • Must have completed at least 5, but no more that 8 courses of primary therapy comprising carboplatin (IV or intraperitoneal) AND paclitaxel or docetaxel-based combination chemotherapy within the past 12 weeks AND have no symptoms of persistent cancer after completion of therapy
    • CT scan of the abdomen and/or pelvis normal
    • CA 125 normal
  • Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV primary peritoneal carcinoma or epithelial ovarian carcinoma (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided the following criteria is met:
    • Must have undergone interval abdominal surgery after at least one but no more than 6 courses of standard chemotherapy
      • Surgery must meet the same criteria as the up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease
      • Patients must have received at least 2 courses after interval abdominal surgery
  • No synchronous primary endometrial cancer or history of primary endometrial cancer, unless all of the following criteria are met:
    • Stage = IB
    • Less than 3 mm invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion
  • No active bleeding
  • No acute or chronic hepatitis
  • Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided the disease has remained stable within the past 6 months
  • No unstable angina
  • No myocardial infarction within the past 6 months
  • No neuropathy (sensory and motor) = grade 2
  • No active infection requiring antibiotics
  • No ongoing gastrointestinal bleeding requiring blood product support
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior biologic therapy (e.g., bevacizumab or erlotinib) for any other abdominal or pelvic tumor
  • No prior polyglutamate paclitaxel
  • No prior chemotherapy for any other abdominal or pelvic tumor
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND no recurrent or metastatic disease
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin AND no recurrent or metastatic disease
IRB Number  
06-05-03A
Principal Investigator  
Higgins, Robert

For More Information, Contact  Mary Frances  , Bussey
Phone:  (704) 355-7627  Fax:  (704) 355-1188  
Email:  Mary.Bussey@carolinashealthcare.org
Address:1025 Morehead Medical Drive
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