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

NCT ID: NCT00033384

Last Updated: 2013-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2003-11-30

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.

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.

Conditions

Breast Cancer; Colorectal Cancer; Lung Cancer; Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

CI-1040

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John J. Rinehart, MD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB-0152

Identifier Type: -

Identifier Source: secondary_id

PFIZER-1040-002-004

Identifier Type: -

Identifier Source: secondary_id

UAB-F011203011

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2052

Identifier Type: -

Identifier Source: secondary_id

CDR0000069279

Identifier Type: -

Identifier Source: org_study_id