CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00033384|
Recruitment Status : Completed
First Posted : July 8, 2003
Last Update Posted : April 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Colorectal Cancer Lung Cancer Pancreatic Cancer||Drug: CI-1040||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer Or Pancreatic Cancer|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||November 2003|
|Actual Study Completion Date :||November 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033384
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|Study Chair:||John J. Rinehart, MD||University of Alabama at Birmingham|