An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
Condition: Genital Neoplasms, Female; Fallopian Tube Neoplasms; Ovarian Neoplasms; Pelvic Neoplasms; Peritoneal Neoplasms
MeSH terms: Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms; Genital Neoplasms, Female; Pelvic Neoplasms
Intervention: Gemcitabine; Paclitaxel; Carboplatin
Intervention description: 1000 mg/m^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles
If anything other than complete response in Paclitaxel arm patients, 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity; 175 mg/m^2, IV, Day 1, q 21 days x 6 cycles
If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m^2, IV, 3 hours q 28 days x 12 cycles (1 year)
If no complete response, then Gemcitabine arm patients may receive 175 mg/m^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity; Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles
Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 919.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase III randomized study comparing induction treatments of Gemcitabine and
      Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for
      patients that do not have any evidence of disease after completion of six cycles of induction
      therapy. Patients with disease after induction therapy will crossover to receive single agent
      therapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients with a histologic diagnosis of primary peritoneal carcinoma, epithelial
             ovarian carcinoma or fallopian tube carcinoma Stage IC, II, III or IV.

          -  All patients must have had surgery for fallopian, ovarian or peritoneal carcinoma to
             establish the diagnosis and have tissue available for histologic evaluation and
             confirmation of organ of origin.

          -  Patients must be enrolled no more than twelve weeks postoperatively.

          -  Patients must be willing to receive their chemotherapy drugs intravenously, as
             intraperitoneal therapy is not part of this trial.

        Key Exclusion Criteria:

          -  Patients with a current diagnosis of epithelial ovarian tumor of low malignant
             potential (Borderline carcinomas) are not eligible.

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis are excluded

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are
             excluded

          -  With the exception of non-melanoma skin cancer and other specific malignancies
             patients who had (or have) any evidence of the other cancer present within the last 5
             years or whose previous cancer treatment contraindicates this protocol therapy are
             excluded.