Chemotherapy in Treating Patients With Advanced Solid Tumors
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: incyclinide||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||November 1998|
|Study Completion Date:||April 2002|
|Primary Completion Date:||April 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003721
|United States, Texas|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States, 78229-3264|
|Study Chair:||Eric K. Rowinsky, MD||San Antonio Cancer Institute|