Recurrent Rectal Cancer Clinical Trial
Official title:
A Phase I/II Study of Escalating Doses of SU5416 (NSC 696819) in Combination With CPT-11 in Patients With Advanced Colorectal Carcinoma
Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating patients who have advanced colorectal cancer. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity of SU5416 in
combination with irinotecan in patients with advanced colorectal cancer.
II. Determine time to disease progression, objective response rate, and survival time in
these patients receiving this regimen at the MTD.
III. Evaluate the safety and tolerance of this regimen in these patients.
OUTLINE: This is a dose-escalation study of SU5416.
Patients receive irinotecan IV over 90 minutes on day 1 of weeks 1-4 and SU5416 IV over 60
minutes on days 1 and 4 of weeks 1-6. Treatment continues every 6 weeks in the absence of
unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, additional patients
are accrued to receive treatment with SU5416 and irinotecan at the recommended phase II
dose.
Patients are followed every 3 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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