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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.
First Received: October 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: American College of Surgeons
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025246
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: imatinib mesylate
Procedure: adjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Adjuvant STI571 Therapy in Patients Following Completely Resected High-Risk Primary Gastrointestinal Stromal Tumor (GIST)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025246

  Show 63 Study Locations
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Ronald DeMatteo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
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.

Study ID Numbers: CDR0000068942, ACOSOG-Z9000, CWRU-020313
Study First Received: October 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00025246     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
gastrointestinal stromal tumor

Study placed in the following topic categories:
Imatinib
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Adjuvants, Immunologic
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Protein Kinase Inhibitors

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

ClinicalTrials.gov processed this record on September 02, 2009