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

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ClinicalTrials.gov Identifier: NCT00033384

Recruitment Status : Completed

First Posted : July 8, 2003

Last Update Posted : April 12, 2013

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer Colorectal Cancer Lung Cancer Pancreatic Cancer	Drug: CI-1040	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Primary Purpose:	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
Actual Primary Completion Date :	November 2003
Actual Study Completion Date :	November 2003

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer Lung cancer

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033384

Locations

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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300

Sponsors and Collaborators

University of Alabama at Birmingham

National Cancer Institute (NCI)

Investigators

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

More Information

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Responsible Party:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00033384
Other Study ID Numbers:	CDR0000069279 UAB-0152 PFIZER-1040-002-004 UAB-F011203011 NCI-G02-2052
First Posted:	July 8, 2003 Key Record Dates
Last Update Posted:	April 12, 2013
Last Verified:	December 2002

Keywords provided by University of Alabama at Birmingham:


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

Additional relevant MeSH terms:

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Breast Neoplasms Lung Neoplasms Pancreatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Respiratory Tract Neoplasms	Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Digestive System Neoplasms Digestive System Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases

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