A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer
- Determine the maximum tolerated dose of topotecan when administered with cisplatin in
patients with advanced cervical cancer.
- Identify any unique toxicities associated with administering radiotherapy along with
adjuvant cisplatin and topotecan in patients with cervical cancer.
- Determine the feasibility of administering continuous infusion topotecan chemotherapy
together with radiation therapy.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of topotecan.
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36.
Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously
(IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5,
8-12, 15-19, 22-26, 29-33, and 36. Treatment continues in the absence of disease progression
or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Quality of life is assessed at baseline and at 4 and 14 weeks after completion of study
After completion of study treatment, patients are followed periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of topotecan
Adequate Response Trial Minimum length of trial to evaluate response is defined as receiving the first course of chemotherapy and living at least three weeks for repeat measurement to be performed.
Week 3 After First Course of Therapy
Linda F. Carson, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|