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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer Or Pancreatic Cancer

Conditions
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Breast Cancer, Colorectal Cancer, Lung Cancer, Pancreatic Cancer

Intervention / Treatment
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* Drug: CI-1040


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CI-1040|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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