Cervical Adenocarcinoma Clinical Trial
Official title:
A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS
This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in
patients with locally advanced cervical cancer.
II. Determine the maximum tolerated dose (MTD) of topotecan when administered in this
regimen in this patient population.
SECONDARY OBJECTIVES:
I. Determine the site of recurrence (local vs distant) in patients treated with this
regimen.
OUTLINE: This is a multicenter, dose-escalation study of topotecan.
Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and
topotecan IV over 30 minutes once weekly for a total of 6 weeks 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 at which 1 of 6 patients
experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20
patients receives treatment as above at the MTD.
After completion of study treatment, patients are followed periodically for 5 years.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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