Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	16 and over	NCI	ACOSOG-Z9000 CWRU-020313, NCT00025246

Special Category: CTSU trial

Objectives

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

Entry Criteria

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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

DeMatteo RP, Owzar K, Antonescu CR, et al.: Efficacy of adjuvant imatinib mesylate following complete resection of localized, primary gastrointestinal stromal tumor (GIST) at high risk of recurrence: the U.S. Intergroup phase II trial ACOSOG Z9000. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-8, 2008.

Dematteo RP, Antonescu CR, Chadaram V, et al.: Adjuvant imatinib mesylate in patients with primary high risk gastrointestinal stromal tumor (GIST) following complete resection: safety results from the U.S. intergroup phase II trial ACOSOG Z9000. [Abstract] J Clin Oncol 23 (Suppl 16): A-9009, 818s, 2005.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Ronald DeMatteo, MD, Protocol chair		Ph: 212-639-5726; 800-525-2225 Email: dematter@mskcc.org

Registry Information
Official Title		A Phase II Study of Adjuvant STI571 Therapy in Patients Following Completely Resected High-Risk Primary Gastrointestinal Stromal Tumor (GIST)
Trial Start Date		2001-09-27
Registered in ClinicalTrials.gov		NCT00025246 1
Date Submitted to PDQ		2001-08-07
Information Last Verified		2001-11-02
NCI Grant/Contract Number		CA76001, CA43703

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00025246