S9912 Combination Chemo in Stage III Ovarian Cancer,
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: cisplatin; liposomal doxorubicin; paclitaxel
Intervention MeSH terms: Paclitaxel; Doxorubicin; Liposomal doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: Female
Healthy volunteers: No
Keywords: stage III ovarian epithelial cancer; peritoneal cavity cancer; fallopian tube cancer

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
      dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and
      liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian
      cancer, fallopian tube cancer, or primary peritoneal cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary
             peritoneal carcinoma

               -  Tumor involves one or both ovaries with microscopically confirmed peritoneal
                  metastasis outside the pelvis and/or regional lymph node metastasis

               -  No tumors of borderline or low malignant potential only

               -  Mixed Mullerian tumors allowed

          -  Must have optimal disease defined as no residual lesions after resection or residual
             disease such that no single lesion measures greater than 1 cm in diameter

          -  Must have undergone staging exploratory laparotomy with tumor debulking within the
             past 70 days

        PATIENT CHARACTERISTICS:

        Age:

          -  Not specified

        Performance status:

          -  SWOG 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic:

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  SGOT or SGPT ≤ 2 times ULN

        Renal:

          -  Creatinine clearance ≥ 50 mL/min

        Cardiovascular:

          -  No congestive heart failure

          -  No cardiac arrhythmia

          -  No myocardial infarction or unstable angina within the past 6 months

          -  Patients with a history of myocardial disease must not have ischemia or pathologic
             arrhythmias and must have an ejection fraction > 50% by MUGA

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No active or uncontrolled infection

          -  No concurrent fever

          -  No grade 2 or greater sensory neuropathy

          -  No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding,
             diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection

          -  No erythema or tenderness of abdominal incision or port site suggestive of underlying
             infection

          -  No other malignancy within the past five years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy for ovarian cancer

        Chemotherapy:

          -  No prior chemotherapy for ovarian cancer

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior pelvic radiotherapy for ovarian cancer

        Surgery:

          -  See Disease Characteristics

          -  Recovered from all reversible surgery-related toxic effects

        Other:

          -  No other concurrent antitumor treatment

          -  No concurrent antibiotics for infection of undetermined etiology