NCT00003721

Chemotherapy in Treating Patients With Advanced Solid Tumors

A Phase I, Pharmacologic and Biologic Study of Col-3 (NSC683551) Administered on a 28-Day Oral Dosing Schedule in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of COL-3 in treating patients who have advanced solid tumors.

Detailed description

OBJECTIVES: I. Define the maximum tolerated dose of COL-3 in patients with advanced solid tumors. II. Identify the dose limiting toxicity and safety profile of COL-3 in these patients. III. Define the pharmacokinetics and pharmacodynamics of COL-3 in these patients. IV. Observe any evidence of antitumor activity through standard response criteria or biologic surrogate markers. OUTLINE: This is a dose escalation study. Patients receive oral COL-3 once daily. Treatment continues in the absence of disease progression and unacceptable toxic effects. Cohorts of 3-6 patients each receive escalating doses of COL-3. Dose escalation to the next level occurs after 3 patients have completed 28 days of treatment without dose limiting toxicity (DLT). Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience DLT. PROJECTED ACCRUAL: Up to 30 patients will be accrued within 1 year for this study.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	incyclinide	This is a dose escalation study. Patients receive oral COL-3 once daily. Treatment continues in the absence of disease progression and unacceptable toxic effects. Cohorts of 3-6 patients each receive escalating doses of COL-3. Dose escalation to the next level occurs after 3 patients have completed 28 days of treatment without dose limiting toxicity (DLT). Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience DLT.

Timeline

• Start date: 1998-11-01
• Primary completion: 2002-04-01
• Completion: 2002-04-01
• First posted: 2004-02-09
• Last updated: 2012-06-29

Locations

1 site across 1 country: United States