Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Lung Cancer
Interventions
DRUG

Topotecan

The starting dose for the first cohort will be 2 mg/m2/week. Increment between cohorts will be by 1 mg/m2/week if no toxicity related to topotecan occurs. All members of a dose cohort must have safely completed all radiotherapy and topotecan dosing prior to beginning enrollment in the next higher dose cohort. Increments will be reduced to 0.5 mg/m2 if mild to moderate toxicity occurs (grades 1 or 2). The escalation will continue until the maximum dose of 4 mg/m2/week is reached. Therefore the minimum number of dose levels (cohorts) is 3 to reach the goal of 4 mg/m2/week, and the maximum is 5.

Trial Locations (1)

87131

University of New Mexico, Albuquerque

All Listed Sponsors
lead

University of New Mexico

OTHER

NCT00322751 - Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer | Biotech Hunter | Biotech Hunter