Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum
Primary Purpose
Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, Platinum Sensitve Relapse, Anemia
Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
paclitaxel, carboplatin, epoetin alpha
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
Eligibility Criteria
Inclusion Criteria: Relapse longer than 6 months after termination of platinum/taxane based first line chemotherapy Previously histologically confirmed cancer of: ovary, fallopian tube, peritoneum measurable and evaluable lesions by ultrasound, computer-tomography or MRI Performance status ECOG < 2 or karnofsky index > 60% normal organ function Exclusion Criteria: more than 1 chemotherapy prior enrollment ongoing treatment with epoetin alpha or related drugs history of thrombosis or embolism during the past 12 months prior enrollment ileus left ventricular failure > NYHA classification > 2 Ongoing toxicity of any kind (> CTC Grad II)
Sites / Locations
- Department of Gynecology University of Marburg
Outcomes
Primary Outcome Measures
Reduction of anemia
Secondary Outcome Measures
Quality of life
Overall survival
Progression free survival
Toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00189371
Brief Title
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum
Official Title
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AGO Study Group
4. Oversight
5. Study Description
Brief Summary
Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Relapse more than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment option. Therapy induced anemia is a common problem resulting in decrease of quality of life. The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of therapy induced anemia, rate of transfusions and on quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, Platinum Sensitve Relapse, Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
paclitaxel, carboplatin, epoetin alpha
Primary Outcome Measure Information:
Title
Reduction of anemia
Secondary Outcome Measure Information:
Title
Quality of life
Title
Overall survival
Title
Progression free survival
Title
Toxicity
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Relapse longer than 6 months after termination of platinum/taxane based first line chemotherapy
Previously histologically confirmed cancer of: ovary, fallopian tube, peritoneum
measurable and evaluable lesions by ultrasound, computer-tomography or MRI
Performance status ECOG < 2 or karnofsky index > 60%
normal organ function
Exclusion Criteria:
more than 1 chemotherapy prior enrollment
ongoing treatment with epoetin alpha or related drugs
history of thrombosis or embolism during the past 12 months prior enrollment
ileus
left ventricular failure > NYHA classification > 2
Ongoing toxicity of any kind (> CTC Grad II)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Jackisch, MD, PhD
Organizational Affiliation
AGO Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gynecology University of Marburg
City
Marburg
ZIP/Postal Code
D-35037
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.ago-ovar.de
Description
homepage of the german ovarian cancer study group AGO
Learn more about this trial
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum
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