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Trial record 5 of 10 for:    "Cervical Adenocarcinoma" | "Topotecan"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003065
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Biological: filgrastim Drug: paclitaxel Drug: topotecan hydrochloride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Primary Purpose: Treatment
Official Title: Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix
Study Start Date : January 1997
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003065

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

Publications of Results:
Layout table for additonal information Identifier: NCT00003065     History of Changes
Other Study ID Numbers: CDR0000065736
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: September 2003

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:
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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