Spots Global Cancer Trial Database for Chemotherapy in Treating Patients With Advanced Solid Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Chemotherapy in Treating Patients With Advanced Solid Tumors

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 ID: NCT00003721

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

incyclinide

Study Description

Brief 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.