Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Condition: Primary Peritoneal Carcinoma; Stage III Ovarian Cancer; Stage IV Ovarian Cancer
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Paclitaxel; Carboplatin; Gemcitabine Hydrochloride; Pegylated Liposomal Doxorubicin Hydrochloride; Topotecan Hydrochloride; Therapeutic Conventional Surgery
Intervention description: Given IV; Given IV; Given IV; Given IV; Undergo surgery
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine; Doxorubicin; Liposomal doxorubicin; Topotecan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4312.0
Sex: Female
Healthy volunteers: No

Summary:

      Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop
      growing or die. It is not yet known which combination chemotherapy regimen is most effective
      in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to
      compare the effectiveness of various combination chemotherapy regimens in treating patients
      who have stage III or stage IV ovarian cancer or primary peritoneal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed stage III or IV ovarian epithelial or serous
             primaryperitoneal carcinoma

          -  The following are ineligible:

               -  Germ cell tumors

               -  Sex cord-stromal tumors

               -  Carcinosarcomas

               -  Mixed Mullerian tumors or carcinosarcomas

               -  Metastatic carcinomas from other sites to theovary

               -  Low malignant potential tumors, including micropapillary serouscarcinomas

               -  Mucinous primary peritoneal carcinoma

          -  Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically
             resected with subsequent development of invasive adenocarcinoma allowed if no prior
             chemotherapy

          -  Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery

          -  Prior breast cancer allowed provided the following are true:

               -  Disease-free for more than 5 years

               -  No prior cytotoxic chemotherapy for breast cancer

          -  Prior or concurrent primary endometrial cancer allowed if the following conditions are
             met:

               -  Stage no greater than 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 lesions

          -  Performance status - GOG 0-2

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST no greater than 2.5 times ULN

          -  Alkaline phosphatase no greater than 2.5 times ULN

          -  No acute hepatitis

          -  Creatinine no greater than 1.5 times ULN

          -  No unstable angina

          -  No myocardial infarction within the past 6 months

          -  No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block)
             unless stable for the past 6 months

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No greater than grade 1 sensory or motor neuropathy

          -  No active infection that requires antibiotics

          -  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

          -  No severe or ongoing gastrointestinal bleeding that requires blood product support

          -  See Disease Characteristics

          -  Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed
             provided the following are true:

               -  More than 3 years since prior therapy

               -  No evidence of recurrent disease

          -  No prior radiotherapy to any portion of the abdominal cavity or pelvis

          -  Prior radiotherapy for localized breast, head and neck, or skin cancer allowed
             provided the following are true:

               -  More than 3 years since prior therapy

               -  No evidence of recurrent disease

          -  See Disease Characteristics

          -  No more than 12 weeks since prior surgical resection