ci-1040 in treating patients with advanced breast, colon, pancreatic, or non-small cell lung cancer

Conditions: Breast Cancer; Colorectal Cancer; Lung Cancer; Pancreatic Cancer

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.

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.

Eligibility 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

Keywords: 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