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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether liposome-encapsulated doxorubicin citrate is more effective when given together with or without gemcitabine hydrochloride in killing tumor cells.

PURPOSE: This randomized phase II trial is studying liposome-encapsulated doxorubicin citrate given together with gemcitabine hydrochloride to see how well it works compared with liposome-encapsulated doxorubicin citrate alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University Innsbruck
• Treatments: Citric Acid; Doxorubicin; Gemcitabine; Liposomal doxorubicin

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