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Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
This study is ongoing, but not recruiting participants.
Study NCT00025246   Information provided by National Cancer Institute (NCI)
First Received: October 11, 2001   Last Updated: February 6, 2009   History of Changes

October 11, 2001
February 6, 2009
September 2001
 
 
 
Complete list of historical versions of study NCT00025246 on ClinicalTrials.gov Archive Site
 
 
 
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
A Phase II Study of Adjuvant STI571 Therapy in Patients Following Completely Resected High-Risk Primary Gastrointestinal Stromal Tumor (GIST)

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with gastrointestinal stromal tumor that was completely removed during surgery.

OBJECTIVES:

  • Determine survival of patients with completely resected high-risk primary gastrointestinal stromal tumor treated with adjuvant imatinib mesylate.
  • Determine the 2- and 5-year rates of recurrence in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive oral imatinib mesylate daily beginning within 84 days of surgical resection. Treatment continues for 1 year in the absence of disease recurrence or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 89 patients will be accrued for this study.

Phase II
Interventional
Treatment
Gastrointestinal Stromal Tumor
  • Drug: imatinib mesylate
  • Procedure: adjuvant therapy
 
 

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-risk primary gastrointestinal stromal tumor

    • High-risk is defined as any of the following:

      • Tumor at least 10 cm in greatest dimension
      • Presence of tumor rupture before or during surgery
      • Intraperitoneal hemorrhage
      • Multifocal intraperitoneal tumors
  • Complete gross tumor resection performed within the past 70 days

    • Includes R0 (negative microscopic margins) and R1 (positive microscopic margins) resection
  • Kit protein positive
  • No residual disease on CT scan or MRI of the abdomen or pelvis

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • No active infection requiring antibiotics within the past 14 days
  • No other prior malignancy within the past 5 years except:

    • Effectively treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix effectively treated by surgery alone
    • Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone
  • At low risk for recurrence of curatively treated prior malignancies
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier-method contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No post-operative chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No post-operative radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No prior imatinib mesylate
  • No post-operative investigational treatment
  • No concurrent full-dose warfarin
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00025246
 
CDR0000068942, ACOSOG-Z9000, CWRU-020313
American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Ronald DeMatteo, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
November 2001

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