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| Sponsors and Collaborators: |
University of Alabama at Birmingham National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033384 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000069279, UAB-0152, PFIZER-1040-002-004, UAB-F011203011, NCI-G02-2052 |
| Study First Received: | April 9, 2002 |
| Last Updated: | May 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00033384 History of Changes |
| 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 Digestive System Neoplasms Skin Diseases Breast Neoplasms Endocrine System Diseases |
Intestinal Diseases Recurrence Intestinal Neoplasms Carcinoma Digestive System Diseases Lung Diseases Non-small Cell Lung Cancer Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Rectal Diseases Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Breast Diseases Endocrine Gland Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Digestive System Neoplasms Skin Diseases |
Endocrine System Diseases Breast Neoplasms Intestinal Diseases Intestinal Neoplasms Carcinoma Neoplasms Digestive System Diseases Lung Diseases Pancreatic Diseases Gastrointestinal Neoplasms Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Neoplasms, Glandular and Epithelial |