Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in
patients with cervical carcinoma limited to the pelvis.
II. Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin
and pelvic radiotherapy in these patients.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival of patients treated with gemcitabine
at the MTD in this regimen.
II. Determine the site of recurrence, local versus distant, in patients treated with this
regimen.
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine.
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8,
15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients
also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27,
and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary
radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all
radiotherapy is not more than 8 weeks.
Cohorts of 3-6 patients receive escalating doses of gemcitabine 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.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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