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Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193297
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011

September 12, 2005
May 2, 2011
February 2002
June 2005   (final data collection date for primary outcome measure)
Overall response rate
Same as current
Complete list of historical versions of study NCT00193297 on ClinicalTrials.gov Archive Site
Overall toxicity
Same as current
Not Provided
Not Provided
 
Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
A Phase II Study of a Three-Day Schedule of Topotecan Plus Paclitaxel and Carboplatin on Day Three in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma

The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.

Upon determination of eligibility, all patients will be receive:

Paclitaxel + Carboplatin + Topotecan

a maximum of six courses of chemotherapy will be given at 21 day intervals

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovary Cancer
  • Drug: Topotecan
  • Drug: Paclitaxel
  • Drug: Carboplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2006
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Epithelial ovarian carcinoma or primary peritoneal carcinoma
  • Willing to consider second-look surgery to evaluate response if necessary
  • No previous treatment with chemotherapy or radiation therapy
  • Ability to perform activities of daily living with minimal assistance
  • Adequate bone marrow, liver and kidney function
  • Written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Age < 18 years
  • Brain metastases
  • Recent history of significant heart disease within 6 months
  • Other significant medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193297
SCRI GYN 08, 104864-644
Not Provided
SCRI Oncology Research Consortium, SCRI
SCRI Development Innovations, LLC
GlaxoSmithKline
Principal Investigator: Anthony Greco, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP