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

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: National Cancer Institute (NCI)

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