Spots Global Cancer Trial Database for CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial