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


Phase 2
18 Years
60 Years
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Amy D. Tiersten, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065736

NCT ID:

NCT00003065

Start Date:

January 1997

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • Uterine Cervical Neoplasms
  • Neoplasm Metastasis

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032