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

NCT ID: NCT00003065

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-01-31
• Study Completion Date: 2004-02-29

Brief Summary

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.

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.

Conditions

Cervical Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

paclitaxel

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Herbert Irving Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Amy D. Tiersten, MD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Countries

United States

References

Tiersten AD, Selleck MJ, Hershman DL, Smith D, Resnik EE, Troxel AB, Brafman LB, Shriberg L. Phase II study of topotecan and paclitaxel for recurrent, persistent, or metastatic cervical carcinoma. Gynecol Oncol. 2004 Feb;92(2):635-8. doi: 10.1016/j.ygyno.2003.11.019.

Reference Type: RESULT

PMID: 14766258 (View on PubMed)

Other Identifiers

CPMC-IRB-7919

Identifier Type: -

Identifier Source: secondary_id

NCI-V97-1324

Identifier Type: -

Identifier Source: secondary_id

CDR0000065736

Identifier Type: -

Identifier Source: org_study_id