Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
Recruitment status was Active, not recruiting
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Purpose
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 |
| Estimated Enrollment: | 25 |
| Study Start Date: | January 1997 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Study Chair: | Amy D. Tiersten, MD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003065 History of Changes |
| Other Study ID Numbers: | CDR0000065736, CPMC-IRB-7919, NCI-V97-1324 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
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 Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Neoplastic Processes Pathologic Processes Paclitaxel Topotecan Lenograstim |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013