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

University of Alabama at Birmingham

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Breast Cancer Colorectal Cancer Lung Cancer Pancreatic Cancer

Interventions

CI-1040DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Data from ClinicalTrials.gov

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