12
Participants
Start Date
August 31, 1998
Primary Completion Date
May 31, 2001
Study Completion Date
May 31, 2001
irinotecan hydrochloride
Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month.
mitomycin C
Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month.
San Antonio Cancer Institute, San Antonio
National Cancer Institute (NCI)
NIH
The University of Texas Health Science Center at San Antonio
OTHER