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Home > "C" Clinical Trials Conditions > CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer  CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer
CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer
For Condition: Pancreatic Cancer,Colorectal Cancer,Colon Cancer,Lung Cancer,Breast Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , UAB Comprehensive Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the antitumor activity of CI-1040 in patients with non-small cell lung, breast, colon, or pancreatic cancer. II. Determine the safety profile of this drug in these patients. III. Assess quality of life (overall and for each tumor type) of patients treated with this drug. IV. Determine the relationship between study drug concentration and antitumor response in these patients and target suppression and safety of this drug. V. Correlate target suppression (pERK) with antitumor effects of this drug in these patients. VI. Correlate the mRNA expression profile of the tumors with antitumor effects of this drug in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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/mm3 - Platelet count at least 100,000/mm3 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnRinehart, Study Chair, UAB Comprehensive Cancer Center
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Additional Information:
Study ID Numbers: CDR0000069279; UAB-F011203011,PFIZER-1040-002-004,NCI-G02-2052,UAB-0152
Study Start Date: February 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033384
Other Lung Cancer Studies:
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2. Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
3. Gene Therapy in Treating Patients With Cancer
4. Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients with Locally Advanced Pancreatic Cancer
5. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
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CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer
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