Liposome-Encapsulated Doxorubicin Citrate With or Without Gemcitabine Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
• •Progression or recurrence during first-line platinum-based chemotherapy (platinum-refractory disease) OR progression or recurrence during the first 6 months following the end of the last platinum-containing chemotherapy (platinum-resistant disease)
• •Meets ≥ 1 of the following criteria:
• •* Measurable metastatic disease on CT or MRI scan, ultrasound, or chest x-ray
• •* Evaluable disease on CT/MRI scan (e.g., ascites or pleural effusion) or chest x-ray (e.g., pleural effusion)
• •* Tumor marker progression (CA-125) according to Rustin criteria, meeting 1 of the following criteria:
• •* CA-125 \> 2 times upper limit of normal (UNL)
• •* CA-125 \> 2 times nadir value on two occasions
• •No ovarian carcinosarcoma (malignant mixed Müllerian tumor) or pure sarcoma
• •PATIENT CHARACTERISTICS:
• •Karnofsky performance status 70-100%
• •Life expectancy ≥ 3 months
• •Platelet count ≥ 100,000/mm³
• •Hemoglobin ≥ 10 g/dL
• •Neutrophil count ≥ 1.5 x 10³/mm³
• •Serum creatinine \< 1.5 times ULN
• •Bilirubin \< 1.5 times ULN (\< 2.5 times ULN if liver metastases are present)
• •AST/ALT \< 2.5 times ULN (unless caused by parenchymal liver metastases)
• •No childbearing capacity
• •LVEF ≥ 50% by ECHO or MUGA scan
• •No significant comorbidity (e.g., uncontrolled infection, clinical signs of cardiac insufficiency, history of myocardial infarction, or cardiac rhythmic disorders \[NYHA class III-IV disease\])
• •No known hypersensitivity to study drugs
• •No active secondary malignant tumor within the past 5 years (e.g., metastases from primary breast cancer)
• •No condition (medical, social, or psychological), that would prevent adequate follow-up
• •PRIOR CONCURRENT THERAPY:
• •No prior chemotherapy with pegylated liposomal doxorubicin hydrochloride, other anthracyclines, or gemcitabine hydrochloride
• •No other concurrent tumor-specific therapy for ovarian cancer