RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients who have refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.

Condition	Treatment or Intervention	Phase
recurrent gastric cancer stage IV gastric cancer recurrent esophageal cancer stage IV esophageal cancer stage III esophageal cancer stage III gastric cancer	Drug: imatinib mesylate  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the response rate and time to tumor progression in patients with refractory metastatic and/or unresectable adenocarcinoma of the stomach treated with imatinib mesylate.
• Determine the overall survival of patients treated with this drug.
• Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [chemonaïve] vs poor risk [1 prior chemotherapy regimen]).

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 1-1.5 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic and/or unresectable adenocarcinoma of the stomach or gastroesophageal junction
• Measurable disease by radiographic imaging
• No brain metastasis

PATIENT CHARACTERISTICS: Age

• Over 18

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 3 months

Hematopoietic

• Granulocyte count greater than 1,500/mm^3
• Platelet count greater than 100,000/mm^3
• Hemoglobin at least 9 g/dL
• No active bleeding disorder

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• SGOT/SGPT less than 2.5 times upper limit of normal

Renal

• Creatinine clearance greater than 60 mL/min

Gastrointestinal

• No active peptic ulceration
• No active gastrointestinal bleeding

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after study completion
• No active infection
• No known seizure disorder
• No medical, social, or psychological factors that would preclude completion of study treatment
• No serious concurrent illness that would preclude tolerance and completion of study treatment

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Recovered from prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Recovered from prior radiotherapy

Surgery

• More than 4 weeks since prior major surgery

Other

• No concurrent therapeutic warfarin for anticoagulation
• No concurrent highly active antiretroviral therapy for HIV-positive patients
• No concurrent grapefruit juice

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
      City of Hope Medical Group, Pasadena,  California,  91105,  United States; Recruiting
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States; Recruiting
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033,  United States; Recruiting
Pennsylvania
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting

Study chairs or principal investigators

Stephen I. Shibata, MD,  Principal Investigator,  Beckman Research Institute   

Study ID Numbers:  CDR0000322257; CCC-PHII-37; 2004-01-09; NCI-5734; NCT00068380
Record last reviewed:  December 2004
Last Updated:  February 7, 2005
Record first received:  September 10, 2003
ClinicalTrials.gov Identifier:  NCT00068380
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08