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

Study Overview

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

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.

OBJECTIVES: * 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.

Breast Cancer
Colorectal Cancer
Lung Cancer
Pancreatic Cancer

DRUG: CI-1040

CDR0000069279
UAB-0152
PFIZER-1040-002-004
UAB-F011203011
NCI-G02-2052

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-04-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-04-10
First Submitted that Met QC Criteria 2003-07-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-04-12
First Posted (ESTIMATED) 2003-07-08	Results First Posted N/A	Last Verified 2002-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

Not specified

Not specified

ECOG 0-2

Not specified

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

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)

Creatinine no greater than 1.5 times ULN

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

At least 2 weeks since prior immunotherapy or biologic therapy

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

See Disease Characteristics
At least 2 weeks since other prior hormonal therapy

See Disease Characteristics
At least 3 weeks since prior radiotherapy and recovered
No concurrent radiotherapy

See Disease Characteristics

No other concurrent anticancer agents

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: John J. Rinehart, MD, University of Alabama at Birmingham

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record