This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: January 3, 2014
Last verified: September 2003

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.

Condition Intervention Phase
Cervical Cancer Biological: filgrastim Drug: paclitaxel Drug: topotecan hydrochloride Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 25
Study Start Date: January 1997
Study Completion Date: February 2004
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


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



  • 18 to physiological 60

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 2 months


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


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


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


  • 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


Biologic therapy:

  • Not specified


  • 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)


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


  • Greater than 4 weeks since prior surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003065

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
Study Chair: Amy D. Tiersten, MD Herbert Irving Comprehensive Cancer Center
  More Information

Publications: Identifier: NCT00003065     History of Changes
Other Study ID Numbers: CDR0000065736
Study First Received: November 1, 1999
Last Updated: January 3, 2014

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasm Metastasis
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplastic Processes
Pathologic Processes
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on September 19, 2017