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

NCT ID: NCT01100372

Last Updated: 2013-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31

Brief 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.

Detailed Description

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; recurrent fallopian tube cancer; recurrent primary peritoneal cavity cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

liposome-encapsulated doxorubicin citrate

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Principal Investigators

Alain Zeimet

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

Innsbruck Universitaetsklinik

Innsbruck, , Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Contact Person

Role: primary

Other Identifiers

MUI-AGO-10

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2008-008746-20

Identifier Type: -

Identifier Source: secondary_id

EU-21028

Identifier Type: -

Identifier Source: secondary_id

CDR0000669716

Identifier Type: -

Identifier Source: org_study_id