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



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

For Condition: stage 4 gastric cancer,recurrent gastric cancer,adenocarcinoma of the stomach
Status: Recruiting
Sponsor(s): California Cancer Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have refractorymetastatic and/or unresectable stomach cancer.
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 nonrandomized, multicenter study. 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of metastatic and/or unresectable adenocarcinoma of the stomach - Measurable disease by radiographic imaging - Failed 1 prior chemotherapy regimen - 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 - See Disease Characteristics - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StephenShibata,  Principal Investigator,  Beckman Research Institute

USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles,  California,  90033
United States
Recruiting Heinz-Josef  Lenz 323-865-3955

University of California Davis Cancer Center *Recruiting*
Sacramento,  California,  95817
United States
Recruiting David  Gandara 916-734-3772


Additional Information:
Study ID Numbers:
  CDR0000322257;  NCI-5734,2004-01-09,CCC-PHII-37
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068380

Other Recurrent Gastric Cancer Studies:
1. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

2. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach

3. Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach Cancer

4. BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With Chemotherapy

5. Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

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

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