NCT00257816

Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma

A Pilot Study of Weekly IV Topotecan and Cisplatin With Concurrent Pelvic Radiation in the Treatment of Stages IB2 - IVA Cervical Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4,000 deaths from this disease. This accounts for approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant systemic cisplatin chemotherapy and radiation have shown high response rates (RR) with improvements in durable remissions and overall survival. Though the incidence and mortality in the U.S. dropped steadily from years 1940 to 2000, there has recently been a plateau, arresting the decline. With the routine addition of systemic Cisplatin (CDDP) chemotherapy to local regional radiation, mortality from advanced cervical cancer in the United States is expected to further decrease. However, further advances in this disease are needed.

Detailed description

All eligible patients with invasive squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix, Stages I-B2, II-B, III-B, and IV-A, will experience clinical staging as permitted by FIGO staging criteria. Primary Objective: Feasibility and toxicity of administering weekly Topotecan among patients with carcinoma of the cervix receiving concurrent pelvic radiation and Cisplatin. Secondary Objective(s): To assess the efficacy of administering weekly Topotecan to patients with carcinoma of the cervix receiving concurrent pelvic radiation and Cisplatin on: * progression-free survival, * overall survival, and * local control Statistic This is a feasibility study. A two phase accrual will be utilized. If none or 1 of the 6 patients in the first Stage of accrual finish the prescribed therapy in over 8 weeks, then the second Stage of accrual (an additional 6 patients) will increase the Topotecan dose to 3 mg//m2 on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles). If 2 or 3 of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, the dose of the Topotecan will remain the same in the second Phase of accrual. If 4 or more of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, there will be no second phase of accrual.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Topotecan	(First stage of accrual, 6 patients)-2 mg/m2 IV on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles) If none or 1 of the 6 patients in the first Stage of accrual finish the prescribed therapy in over 8 weeks, then the second Stage of accrual (an additional 6 patients) will increase the Topotecan dose to 3 mg/m2 on days 1, 8, 15, 22, 29 and once during parametrical boost (6 cycles). If 2 or 3 of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, the dose of the Topotecan will remain the same in the second Phase of accrual. If 4 or more of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, there will be no second phase of accrual.
DRUG	Cisplatin	40 mg/m2 IV (Maximum total dose of 70 mg) on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles)

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-12-17
• Completion: 2007-12-17
• First posted: 2005-11-23
• Last updated: 2018-02-05

Locations

1 site across 1 country: United States