Expired Study
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Birmingham, Alabama 35294


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00033384


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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