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Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033384 |
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 | Intervention | Phase |
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Breast Cancer Colorectal Cancer Lung Cancer Pancreatic Cancer |
Drug: CI-1040 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Bidimensionally measurable lesions that are not previously irradiated
No brain metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3300 |
Study Chair: | John J. Rinehart, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Study ID Numbers: | CDR0000069279, UAB-0152, PFIZER-1040-002-004, UAB-F011203011, NCI-G02-2052 |
Study First Received: | April 9, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00033384 |
Health Authority: | United States: Federal Government |
stage III colon cancer stage IV colon cancer stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer recurrent non-small cell lung cancer stage II pancreatic cancer |
stage III pancreatic cancer recurrent pancreatic cancer recurrent colon cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer duct cell adenocarcinoma of the pancreas stage IV pancreatic cancer |
Thoracic Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Pancrelipase Rectal Diseases Respiratory Tract Diseases Lung Neoplasms Breast Diseases Endocrine Gland Neoplasms Non-small cell lung cancer Digestive System Neoplasms Skin Diseases Breast Neoplasms |
Endocrine System Diseases Intestinal Diseases Recurrence Intestinal Neoplasms Carcinoma Digestive System Diseases Lung Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site |