A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS
Overview
- Phase
- Phase 1
- Intervention
- Topotecan Hydrochloride Liposomes
- Conditions
- Cervical Adenocarcinoma
- Sponsor
- Gynecologic Oncology Group
- Enrollment
- 11
- Locations
- 10
- Primary Endpoint
- Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed primary invasive carcinoma of the uterine cervix
- •Stages IB2, II, IIIB, and IVA disease
- •Any cell type
- •No known metastasis to scalene nodes or organs outside the radiation field
- •No known intraperitoneal metastases
- •No evidence of extrapelvic disease based on negative CT or PET scan
- •Must enroll within 8 weeks of diagnosis
- •Performance status - GOG 0-2
- •Absolute neutrophil count ≥ 1,500/mm\^3
- •Platelet count ≥ 100,000/mm\^3
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (topotecan hydrochloride, radiation, cisplatin)
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.
Intervention: Topotecan Hydrochloride Liposomes
Treatment (topotecan hydrochloride, radiation, cisplatin)
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.
Intervention: 3-Dimensional Conformal Radiation Therapy
Treatment (topotecan hydrochloride, radiation, cisplatin)
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.
Intervention: Cisplatin
Outcomes
Primary Outcomes
Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC)
Time Frame: Up to 5 years
Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0
Time Frame: Up to 30 days after completion of radiation therapy
Secondary Outcomes
- Site of treatment failure(Up to 5 years)