S0200 Carboplatin With or Without Doxil in Patients With Recurrent Ovarian Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial carcinoma

  • Stage III or IV disease at time of initial staging laparotomy
• Primary peritoneal and mixed Mullerian tumors allowed
• No borderline ovarian tumors
• Disease progression or recurrence after a progression-free and platinum-free interval of 6-24 months after completion of first-line platinum-based chemotherapy (either single agent or combination therapy)

• Disease progression or recurrence based solely on CA 125 elevation allowed, provided that one of the following is true:

  • Prior baseline CA 125 greater than 35 U/mL and subsequent normalization of no greater than 35 U/mL must have CA 125 greater than 2 times upper limit of normal (ULN) on 2 occasions at least 1 week apart
  • Prior baseline CA 125 greater than 35 U/mL that never normalized must have CA 125 greater than 2 times the nadir value on 2 occasions at least 1 week apart
  • Prior normal baseline CA 125 (no greater than 35 U/mL) must show CA 125 greater than 2 times ULN on 2 occasions at least 1 week apart
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic

• SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2 times ULN
• Bilirubin no greater than ULN

Renal

• Creatinine no greater than 1.9 mg/dL

Cardiovascular

• No New York Heart Association class II-IV cardiac disease
• No clinical evidence of congestive heart failure
• Ejection fraction greater than 50% by MUGA or 2-dimensional echocardiogram

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• 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 incidental carcinoid cancer
• No evidence of active or uncontrolled infection
• No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding or diarrhea
• No greater than grade 1 preexisting sensory neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 28 days since prior biologic consolidation therapy
• No concurrent immunotherapy

Chemotherapy

• See Disease Characteristics
• At least 28 days since prior non-platinum-containing consolidation chemotherapy
• No prior pegylated doxorubicin HCl liposome
• No prior cumulative anthracycline (e.g., doxorubicin, daunorubicin, epirubicin) dose in excess of 240 mg/m^2
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• No prior abdominopelvic irradiation
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• At least 28 days since prior surgical debulking for disease progression or recurrence and recovered
• No concurrent surgery

Other

• No other prior treatment during the 6-24 month progression-free and platinum-free interval except up to 12 courses of consolidation therapy
• No other concurrent anticancer therapy