Imatinib Mesylate With or Without Surgery in Treating Patients With Metastatic Gastrointestinal Stromal Tumor That is Responding to Imatinib Mesylate

NCT00956072 | Terminated Phase 3

• 4 other identifiers: EORTC-62063EU-20955EUDRACT-2007-002257-23NOVARTIS-EORTC-62063
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Surgery may remove residual disease in patients with gastrointestinal stromal tumor that is responding to imatinib mesylate. It is not yet known whether surgery is more effective than continued imatinib mesylate in treating patients with metastatic gastrointestinal stromal tumor. PURPOSE: This randomized phase III trial is studying giving imatinib mesylate therapy together with surgery to see how well it works compared with imatinib mesylate alone in treating patients with metastatic gastrointestinal stromal tumor that is responding to imatinib mesylate.

Conditions

Gastrointestinal Stromal Tumor

Keywords

gastrointestinal stromal tumor

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (5)

• Overall survival

• Pathological response to imatinib mesylate according to RECIST criteria

• Rate of complete resection

• Surgical morbidity

• Quality of life as measured by EORTC QLQ-C30

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo surgery of residual disease.

Procedure: therapeutic conventional surgery

Arm II

ACTIVE COMPARATOR

Patients receive imatinib mesylate therapy according to standard of care.

Drug: imatinib mesylate

Interventions

imatinib mesylate DRUG

Patients receive imatinib mesylate

Arm II

therapeutic conventional surgery PROCEDURE

Patients undergo surgery

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed gastrointestinal stromal tumor expressing CD117+ or with documented mutation of the KIT or PDGFRA gene * Metastatic disease (liver and/or abdominal cavity) * No extra-abdominal metastases * Measurable disease according to RECIST criteria * Achieved complete response, partial response, or stable disease without progression since the start of imatinib mesylate therapy, documented according to RECIST * Underwent 6-12 months of treatment with imatinib mesylate as a standard of care or within other clinical studies (surgery should be feasible before the end of the 12th month from imatinib mesylate onset) * Surgically resectable residual disease as assessed by CT scan and/or MRI within the past 14 days PATIENT CHARACTERISTICS: * WHO performance status 0-1 * ANC \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * Creatinine \< 120 μmol/L * Albumin \> 25 g/L * Total bilirubin \< 2 times upper limit of normal (ULN) * AST and ALT \< 2.5 times ULN (\< 5 ULN in case of liver metastases) * Alkaline phosphatase \< 2.5 times ULN (\< 5 ULN in case of bone or liver metastases) * Negative pregnancy test within the past 14 days * Fertile patients must use effective contraception * No uncontrolled hypertension (diastolic BP \> 95 mm Hg and systolic BP \> 170 mm Hg) * No myocardial infarction, unstable, or uncontrolled cardiac disease within the past 6 months * No history of arterial thrombosis or deep vein thrombosis within the past year * No bleeding diathesis, coagulopathy, or major bleeding within the past 6 months * No severe and/or uncontrolled concurrent medical disease, including any of the following conditions: * Diabetes * Chronic renal disease * Liver disease, including chronic viral hepatitis judged at risk of reactivation * Active infection, including HIV infection * No prior malignancy (other than in situ cervical cancer, in situ melanoma, or basal cell or squamous cell cancer of the skin) unless treated with curative intent and without evidence of disease for at least 3 years * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior adjuvant or neo-adjuvant imatinib mesylate or other tyrosine kinase inhibitor * No coumadin-type anticoagulant \> 2mg/day within the past 7 days * No major surgery within the past 28 days * No medication that interacts moderately or strongly with the CYP3A system within the past 14 days

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

European Organization for Research and Treatment of Cancer

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Alessandro Gronchi

  Istituto Nazionale per lo Studio e la Cura dei Tumori

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2009
• First Posted: August 11, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2011
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

IT (1)