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Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach or Gastroesophageal Junction Cancer
This study is ongoing, but not recruiting participants.
Study NCT00068380   Information provided by National Cancer Institute (NCI)
First Received: September 10, 2003   Last Updated: July 23, 2008   History of Changes

September 10, 2003
July 23, 2008
March 2004
 
Response rate as measured by RECIST every 8 weeks [ Designated as safety issue: No ]
Response rate as measured by RECIST every 8 weeks
Complete list of historical versions of study NCT00068380 on ClinicalTrials.gov Archive Site
  • Time to progression every 8 weeks [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to progression every 8 weeks
  • Overall survival
 
Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach or Gastroesophageal Junction Cancer
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer

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.

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.

Phase II
Interventional
Treatment, Open Label
  • Esophageal Cancer
  • Gastric Cancer
Drug: imatinib mesylate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
41
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068380
 
CDR0000322257, CCC-PHII-37, 2004-01-09, NCI-5734
California Cancer Consortium
National Cancer Institute (NCI)
Principal Investigator: Heinz-Josef Lenz, MD USC/Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP