S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: carboplatin; paclitaxel; debulking surgery
Intervention description: pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles; pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles; exploratory laparotomy, interval cytoreduction (to < 1 cm residual)
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; ovarian undifferentiated adenocarcinoma; ovarian serous cystadenocarcinoma; ovarian mucinous cystadenocarcinoma; ovarian endometrioid adenocarcinoma; ovarian clear cell cystadenocarcinoma; fallopian tube cancer; peritoneal cavity cancer

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug or combining chemotherapy with surgery
      may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in
      treating patients who have stage III or stage IV ovarian epithelial cancer, primary
      peritoneal cancer, or fallopian tube cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer,
             primary peritoneal cancer, or fallopian tube cancer

               -  Adenocarcinoma

               -  Large pelvic mass and/or bulky abdominal disease and/or malignant pleural
                  effusion

               -  Pleural effusion only for stage IV (parenchymal, liver, lung, or other distant
                  metastases not allowed)

               -  No borderline or low-malignant potential tumors

          -  Optimal cytoreduction clinically deemed unlikely

          -  CA 125 at least 70 units/mL

        PATIENT CHARACTERISTICS:

        Age:

          -  Not specified

        Performance status:

          -  Zubrod 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 2 times upper limit of normal (ULN)

          -  SGOT no greater than 2 times ULN

        Renal:

          -  Creatinine clearance at least 50 mL/min

        Cardiovascular:

          -  No congestive heart failure or cardiac arrhythmia

          -  No myocardial infarction or angina within past 6 months

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No severe gastrointestinal symptoms (i.e., partial obstruction) and/or
             gastrointestinal bleeding

          -  No grade 2 or greater sensory neuropathy

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately
             treated stage I or II cancer in complete remission

          -  No active or uncontrolled infection

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy for this cancer

        Chemotherapy:

          -  No prior chemotherapy for this cancer

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior pelvic radiation for this cancer

        Surgery:

          -  See Disease Characteristics

          -  Prior exploratory laparotomy allowed provided an aggressive tumor debulking procedure
             was not performed (e.g., bilateral salpingo-oophorectomy/total abdominal hysterectomy
             with omentectomy)

          -  Prior salpingo-oophorectomy and/or partial omentectomy allowed

        Other:

          -  No other concurrent anti-cancer therapy