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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT00033384

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

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

Study Type:

Interventional

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 :

Feb 1, 2002

Actual Primary Completion Date :

Nov 1, 2003

Actual Study Completion Date :

Nov 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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