A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer - Full Text View

Purpose

CI-1040 is an experimental drug that is being tested in patients who have advanced colorectal and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who have failed no more than 2 prior regimens and in patients with pancreatic cancer who have received no prior chemotherapy. CI-1040 is taken orally twice daily with meals. Patients are required to have blood tests periodically while receiving treatment and will be monitored closely throughout the trial for possible side effects and for response.

Condition	Intervention	Phase
Colorectal Neoplasms Breast Neoplasms Carcinoma, Non-Small-Cell Lung Pancreatic Neoplasms	Drug: CI-1040	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Colorectal Cancer Lung Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall objective response and clinical benefit response

Secondary Outcome Measures:

Time to objective response, duration of response, time to progression and survival

Estimated Enrollment:	172
Study Start Date:	January 2002
Study Completion Date:	May 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are at least 18 years or older who have pathological or hiostological confirmation of colorectal, nonsmall cell lung cancer, breast, or pancreas cancer.
No more than 1 prior chemo for lung or colon cancer, no more than 2 for breast no prior chemotherapy for pancreas cancer.
Original or recent tumor tissue must be available.
Patients must have been off prior chemoptherapy for 4 weeks and radiation for 3 weeks.
Patients must have adequate renal, liver, and bone marrow function, not have serious infection or life-threatening illness (unrelated to tumor).
Must be able to swallow capsules and not have gastrointestinal disorders that may affect absorption of the drug.

Exclusion Criteria:

Unstable medical condition
prior chemotherapy within 4 week of screening
series infection
other tumor types
ECOG performance status of 3 or 4.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034827

Locations


United States, Alabama
	Pfizer Investigational Site
	Birmingham, Alabama, United States, 35205
	Pfizer Investigational Site
	Birmingham, Alabama, United States, 35233

United States, California
	Pfizer Investigational Site
	Los Angeles, California, United States, 90048
	Pfizer Investigational Site
	Blendora, California, United States, 91740
	Pfizer Investigational Site
	Glendale, California, United States, 91204
	Pfizer Investigational Site
	Huntington Beach, California, United States, 92648
	Pfizer Investigational Site
	Long Beach, California, United States, 90813
	Pfizer Investigational Site
	Rancho Cucamonga, California, United States, 91730
	Pfizer Investigational Site
	Los Angeles, California, United States, 90095
	Pfizer Investigational Site
	Mission Hills, California, United States, 91345
	Pfizer Investigational Site
	Northridge, California, United States, 91328
	Pfizer Investigational Site
	Oxnard, California, United States, 93030
	Pfizer Investigational Site
	Pasadena, California, United States, 91105
	Pfizer Investigational Site
	Pomona, California, United States, 91767
	Pfizer Investigational Site
	Los Alamitos, California, United States, 90720
	Pfizer Investigational Site
	Redondo Beach, California, United States, 90277
	Pfizer Investigational Site
	Santa Monica, California, United States, 90404
	Pfizer Investigational Site
	Torrance, California, United States, 90505
	Pfizer Investigational Site
	Ventura, California, United States, 93003
	Pfizer Investigational Site
	West Covina, California, United States, 91790

United States, Georgia
	Pfizer Investigational Site
	Atlanta, Georgia, United States, 30342
	Pfizer Investigational Site
	Decatur, Georgia, United States, 30033
	Pfizer Investigational Site
	Macon, Georgia, United States, 30342

United States, Kentucky
	Pfizer Investigational Site
	Crestview Hills, Kentucky, United States, 41017

United States, Michigan
	Pfizer Investigational Site
	Detroit, Michigan, United States, 48201

United States, Minnesota
	Pfizer Investigational Site
	Rochester, Minnesota, United States, 55905

United States, Ohio
	Pfizer Investigational Site
	Cincinnait, Ohio, United States, 45236
	Pfizer Investigational Site
	Cincinnati, Ohio, United States, 45242
	Pfizer Investigational Site
	Cincinnati, Ohio, United States, 45230
	Pfizer Investigational Site
	Cincinnati, Ohio, United States, 45219

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	1040-000-002
First Received:	May 2, 2002
Last Updated:	May 3, 2007
ClinicalTrials.gov Identifier:	NCT00034827
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms

Gastrointestinal Diseases

Pancreatic Neoplasms

Colonic Diseases

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

Intestinal Neoplasms

Carcinoma

Digestive System Diseases

Lung Diseases

Gastrointestinal Neoplasms

Pancreatic Diseases

Endocrinopathy

Carcinoma, Non-Small-Cell Lung

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00034827