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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003065
• Other study ID #: CDR0000065736
• Secondary ID: CPMC-IRB-7919NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: January 3, 2014
• Start date: January 1997
• Est. completion date: February 2004

Study information

• Verified date: September 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Neoplasm Metastasis
• Uterine Cervical Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• paclitaxel

• topotecan hydrochloride

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Herbert Irving Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation