Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

December 17, 2007

Study Completion Date

December 17, 2007

Conditions
Cervical Cancer
Interventions
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)

Trial Locations (1)

92868

Chao Family Comprehensive Cancer Center, Orange

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

University of California, Irvine

OTHER