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