Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach or Gastroesophageal Junction Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI	CCC-PHII-37 2004-01-09, NCI-5734, NCT00068380, 5734

Objectives

1. 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.
2. Determine the overall survival of patients treated with this drug.
3. Determine the toxic effects of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of metastatic and/or unresectable adenocarcinoma of the stomach or gastroesophageal junction



• Measurable disease by radiographic imaging



• No brain metastasis

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

Patient Characteristics:

Age

• Over 18

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 3 months

Hematopoietic

• Granulocyte count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Response rate as measured by RECIST every 8 weeks

Time to progression every 8 weeks
Overall survival

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.

Trial Contact Information

Trial Lead Organizations

California Cancer Consortium

Heinz-Josef Lenz, MD, Principal investigator		Ph: 323-865-3955; 800-865-0102 Email: lenz_h@ccnt.usc.edu

Registry Information
Official Title		A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
Trial Start Date		2004-03-31
Registered in ClinicalTrials.gov		NCT00068380
Date Submitted to PDQ		2003-07-18
Information Last Verified		2006-04-17
NCI Grant/Contract Number		CM17101, CA33572

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