A Phase III Study of Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients With Recurrent Epithelial Ovarian and Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy

Inclusion Criteria

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