search
Back to results

Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Malignant Tumor of Peritoneum

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Paclitaxel
Topotecan
Carboplatin
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Relapse within 6 months, Previously received taxane derivative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients aged > 18 Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum Peritoneal and/or nodes and/or visceral metastases Disease in progression under treatment or within 6 months after a first or second platinum-based line A period of 3 weeks between last chemotherapy and inclusion Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria) ECOG performance status < 2 Life expectancy of at least 12 weeks Exclusion Criteria: Previously received weekly administration of paclitaxel chemotherapy Involved in a trial within the last 30 days Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy Prior diagnosis of malignancy History of ischemic cardiopathy, congestive heart failure (New York Heart Association [NYHA] > 2), arrhythmia, hypertension, or significant valvulopathy Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 2 Bone marrow, renal, or hepatic insufficiency Severe active infection or occlusive or sub-occlusive disease History of symptomatic brain metastases Fertile women not using adequate contraceptive methods Pregnant or breast feeding women Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin

Sites / Locations

  • Hôpital Hotel Dieu

Outcomes

Primary Outcome Measures

Progression-free survival of patients in the three groups

Secondary Outcome Measures

Overall survival
Rate of response and rate of progression at the end of treatment
Qualitative and quantitative toxicities
Quality of life

Full Information

First Posted
September 12, 2005
Last Updated
February 24, 2011
Sponsor
ARCAGY/ GINECO GROUP
search

1. Study Identification

Unique Protocol Identification Number
NCT00189566
Brief Title
Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse
Official Title
National, Randomized, Phase II Study Comparing Efficacy of Weekly Administration of Paclitaxel in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ARCAGY/ GINECO GROUP

4. Oversight

5. Study Description

Brief Summary
This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.
Detailed Description
The main purpose of this research study is to find out if treatment of early relapse of ovarian or fallopian tube or peritoneal cancer with paclitaxel (Taxol*) weekly administered, in lower doses in combination with topotecan (Hycamtin*) or carboplatin will improve efficacy compared to weekly administration of paclitaxel in monotherapy. Tolerance in the three groups will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Malignant Tumor of Peritoneum
Keywords
Relapse within 6 months, Previously received taxane derivative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Primary Outcome Measure Information:
Title
Progression-free survival of patients in the three groups
Secondary Outcome Measure Information:
Title
Overall survival
Title
Rate of response and rate of progression at the end of treatment
Title
Qualitative and quantitative toxicities
Title
Quality of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged > 18 Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum Peritoneal and/or nodes and/or visceral metastases Disease in progression under treatment or within 6 months after a first or second platinum-based line A period of 3 weeks between last chemotherapy and inclusion Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria) ECOG performance status < 2 Life expectancy of at least 12 weeks Exclusion Criteria: Previously received weekly administration of paclitaxel chemotherapy Involved in a trial within the last 30 days Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy Prior diagnosis of malignancy History of ischemic cardiopathy, congestive heart failure (New York Heart Association [NYHA] > 2), arrhythmia, hypertension, or significant valvulopathy Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 2 Bone marrow, renal, or hepatic insufficiency Severe active infection or occlusive or sub-occlusive disease History of symptomatic brain metastases Fertile women not using adequate contraceptive methods Pregnant or breast feeding women Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure Chauvenet, MD, PhD
Organizational Affiliation
Hôpital Hôtel Dieu
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Hotel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France

12. IPD Sharing Statement

Learn more about this trial

Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse

We'll reach out to this number within 24 hrs