Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | Over 18 | NCI, Other | CDR0000322257 P30CA033572, CCC-PHII-37, 2004-01-09, NCI-5734, 5734, NCT00068380 |
Summary
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 with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.
Further Study Information
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.
Eligibility 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
Trial Lead Organizations/Sponsors
California Cancer Consortium
National Cancer Institute| Heinz-Josef Lenz |  | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00068380
Information obtained from ClinicalTrials.gov on December 14, 2011
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