MedTrace Logo

Chemotherapy in Treating Patients With Advanced Solid Tumors

NCT00003721 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2012-06-29

No results posted yet for this study

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.

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Eric K. Rowinsky, MD · San Antonio Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-11-30
Primary Completion
2002-04-30
Completion
2002-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003721 on ClinicalTrials.gov