Back to resultsLiposome-Encapsulated Doxorubicin Citrate With or Without Gemcitabine Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
Primary Purpose
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Status
Unknown status
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
gemcitabine hydrochloride
liposome-encapsulated doxorubicin citrate
quality-of-life assessment
Sponsored by
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cavity cancer
Eligibility 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
Sites / Locations
- Innsbruck UniversitaetsklinikRecruiting
Outcomes
Primary Outcome Measures
Remission rates (complete response and partial response)
Secondary Outcome Measures
Quality of life as measured by EORTC-QLQ30 and QLQ-OV28 questionnaires
Progression-free survival
Overall survival
Toxicity
Full Information
NCT ID
NCT01100372
First Posted
April 7, 2010
Last Updated
August 23, 2013
Sponsor
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT01100372
Brief Title
Liposome-Encapsulated Doxorubicin Citrate With or Without Gemcitabine Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University Innsbruck
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cavity cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
liposome-encapsulated doxorubicin citrate
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Remission rates (complete response and partial response)
Secondary Outcome Measure Information:
Title
Quality of life as measured by EORTC-QLQ30 and QLQ-OV28 questionnaires
Title
Progression-free survival
Title
Overall survival
Title
Toxicity
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Zeimet
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innsbruck Universitaetsklinik
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
43-512-504-24155
Email
Alain.zeimet@i-med.ac.at
12. IPD Sharing Statement
Learn more about this trial
Liposome-Encapsulated Doxorubicin Citrate With or Without Gemcitabine Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
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