Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung 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.

Detailed description: 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: 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

Relevance to patient case: not relevant