Clinical trial NCT00003065: Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
Official title: Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center at Columbia University
state: New York
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Amy D. Tiersten, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/j.ygyno.2003.11.019.