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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01100372
• Other study ID #: CDR0000669716
• Secondary ID: MUI-AGO-10EUDRAC
• Status: Recruiting
• Phase: Phase 2
• First received: April 7, 2010
• Last updated: August 23, 2013
• Start date: July 2009

Study information

• Verified date: April 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• gemcitabine hydrochloride

• liposome-encapsulated doxorubicin citrate

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rates (complete response and partial response)			No
Secondary	Quality of life as measured by EORTC-QLQ30 and QLQ-OV28 questionnaires			No
Secondary	Progression-free survival			No
Secondary	Overall survival			No
Secondary	Toxicity			Yes