CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer

NCT00033384 | Completed Phase 2 DMC

• 5 other identifiers: CDR0000069279UAB-0152PFIZER-1040-002-004UAB-F011203011NCI-G02-2052
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colorectal Cancer; Lung Cancer; Pancreatic Cancer

Keywords

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

Interventions

CI-1040 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic or inoperable non-small cell lung, breast, or colon cancer or duct cell carcinoma of the exocrine pancreas * Bidimensionally measurable lesions that are not previously irradiated * New lesions that have developed in a previously irradiated field may be used as measurable disease * No brain metastases * Patients with prior brain metastases are allowed provided they have undergone prior resection of metastases and/or 1 prior course of cranial irradiation, have no new sites of brain metastases since then, have no worsening CNS symptoms, and have discontinued prior corticosteroids for at least 30 days * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Not specified Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST or ALT no greater than 2 times ULN (5 times ULN if due to liver involvement) Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after study participation * Capable of swallowing intact study medication capsules * Capable of following instructions regarding study medication or has daily caregiver to administer study medication * No concurrent serious infection * No life-threatening illness unrelated to tumor * No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 2 weeks since prior immunotherapy or biologic therapy Chemotherapy: * At least 4 weeks since prior cytotoxic chemotherapy * No more than 1 prior cytotoxic chemotherapy regimen for metastatic non-small cell lung or colon cancer * No more than 2 prior cytotoxic chemotherapy regimens for breast cancer * No prior cytotoxic chemotherapy for pancreatic cancer Endocrine therapy: * See Disease Characteristics * At least 2 weeks since other prior hormonal therapy Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No other concurrent anticancer agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Colonic Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

2-(2-chloro-4-iodophenylamino)-N-cyclopropylmethoxy-3,4-difluorobenzamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• John J. Rinehart, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: July 8, 2003
• Study Start: February 1, 2002
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: April 12, 2013

Record last verified: 2002-12

Locations

US (1)