Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

January 3, 2014 updated by: Herbert Irving Comprehensive Cancer Center

Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the response, time to progression, disease free survival, and overall survival of patients with recurrent and/or metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel.
  • Determine the feasibility and toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Filgrastim (G-CSF) is administered on days 6-14. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 weeks.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent, persistent or metastatic cervical carcinoma (squamous or adenocarcinoma), with no potentially curative standard treatment
  • Measurable disease or evaluable disease

PATIENT CHARACTERISTICS:

Age:

  • 18 to physiological 60

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 2 months

Hematopoietic:

  • WBC greater than 3000/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Bilirubin less than 1.5 times normal
  • SGOT/SGPT less than 1.5 times normal

Renal:

  • BUN less than 1.5 times normal
  • Creatinine less than 1.5 times normal
  • Creatinine clearance greater than 50 mL/min

Other:

  • Ineligible for other high priority national or institutional study
  • Not pregnant or nursing
  • HIV negative
  • No prior malignancy except nonmelanoma skin cancer
  • No serious medical or psychiatric illness preventing treatment or informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Greater than 4 weeks since prior chemotherapy
  • No greater than 2 prior chemotherapy regimens
  • No prior taxane or camptothecin

Endocrine therapy:

  • No concurrent hormonal therapy except that required for nondisease related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • Greater than 4 weeks since prior radiation therapy
  • No concurrent radiation therapy

Surgery:

  • Greater than 4 weeks since prior surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herbert Irving Comprehensive Cancer Center

Investigators

  • Study Chair: Amy D. Tiersten, MD, Herbert Irving Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

September 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065736
  • CPMC-IRB-7919
  • NCI-V97-1324

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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