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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary To assess the response rate to liposome-encapsulated doxorubicin citrate and gemcitabine hydrochloride versus liposome-encapsulated doxorubicin citrate alone in patients with platinum-refractory or platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Secondary To assess the quality of life of patients treated with these regimens. To determine the progression-free and overall survival of patients treated with these regimens. To determine the toxicity of these regimens. OUTLINE: This is a multicenter study. Patients are stratified according to disease (platinum-refractory disease vs platinum-resistant disease. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive liposome-encapsulated doxorubicin citrate IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive liposome-encapsulated doxorubicin citrate IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who experience clinical benefit after completion of 6 courses of chemotherapy may continue therapy at the discretion of the investigator. Patients complete quality-of-life questionnaires (EORTC-QLQ30 and QLQ-OV28) at baseline, during, and after completion of study therapy. After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Official Title
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Randomized Phase II AGO-Study Comparing Combined Liposomal Doxorubicin (Myocet) and Gemcitabine (Gemzar) With Liposomal Doxorubicin (Myocet) Monotherapy in Platinum-Refractory and Platinum-Resistant Epithelial Cancer of the Ovary, Fallopian Tube and the Peritoneum

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: liposome-encapsulated doxorubicin citrate
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: liposome-encapsulated doxorubicin citrate|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rates (complete response and partial response) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as measured by EORTC-QLQ30 and QLQ-OV28 questionnaires |  |  | 
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cavity cancer