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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
paclitaxel
topotecan hydrochloride
Sponsored by
Herbert Irving Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 3, 2014
Sponsor
Herbert Irving Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00003065
Brief Title
Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
Official Title
Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy D. Tiersten, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14766258
Citation
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.
Results Reference
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Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

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