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Efficacy Study of Weekly Taxotere and Topotecan for Recurrent Gynecologic (GYN) Cancers

NCT00231855 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-04-24

No results posted yet for this study

Summary

The primary aim of this study is:

* To determine the overall clinical response rate of weekly Topotecan and Taxotere in women with recurrent ovarian, primary peritoneal, endometrial and uterine cancers.

The secondary aims of this study are:

* To evaluate the safety and tolerability of the combination therapy with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial or uterine cancers.
* To determine the progression free survival and overall survival in women treated with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial and uterine cancers who have been previously treated with chemotherapy and/or radiation therapy.

Conditions

  • Ovarian Neoplasms
  • Uterine Neoplasms

Interventions

DRUG

Topotecan and Taxotere

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Mark H Einstein, M.D., M.S. · Montefiore Medical Center and Albert Einstein College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Completion
2007-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00231855 on ClinicalTrials.gov