National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
Phase II Study of Imatinib Mesylate in Patients With Refractory Metastatic and/or Unresectable Adenocarcinoma of the Stomach or Gastroesophageal Junction
Last Modified: 8/4/2006     First Published: 8/24/2003  

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

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedOver 18NCICCC-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

41

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

Outcomes

Primary Outcome(s)

Response rate as measured by RECIST every 8 weeks

Secondary Outcome(s)

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 1
Date Submitted to PDQ 2003-07-18
Information Last Verified 2006-04-17
NCI Grant/Contract Number CM17101, CA33572

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.



Table of Links

1http://clinicaltrials.gov/ct/show/NCT00068380