CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Breast Cancer; Colorectal Cancer; Lung Cancer; Pancreatic Cancer

• Registration Number: NCT00033384
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

RATIONALE: CI-1040 may stop the growth of tumors by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of CI-1040 in treating patients who have metastatic or unresectable breast, colon, pancreatic, or non-small cell lung cancer.

Detailed Description

OBJECTIVES:

* Determine the antitumor activity of CI-1040 in patients with non-small cell lung, breast, colon, or pancreatic cancer.

* Determine the safety profile of this drug in these patients.

* Assess quality of life (overall and for each tumor type) of patients treated with this drug.

* Determine the relationship between study drug concentration and antitumor response in these patients and target suppression and safety of this drug.

* Correlate target suppression (pERK) with antitumor effects of this drug in these patients.

* Correlate the mRNA expression profile of the tumors with antitumor effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (non-small cell lung vs breast vs colon vs pancreas).

Patients receive oral CI-1040 twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 28 days during the first 6 months of study therapy.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 52-172 patients (13-43 per stratum) will be accrued for this study.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2002-04-09
• Status Verified: 2002-12
• Study First Submitted QC: 2003-07-07
• Study First Posted: 2003-07-08
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States