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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A Phase III Randomized Study Evaluating Surgery of Residual Disease in Patients With Metastatic Gastro-intestinal Stromal Tumor Responding to Imatinib Mesylate.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Evaluate whether surgery of residual disease improves the progression-free survival of patients with metastatic gastrointestinal stromal tumor responding to imatinib mesylate.

Secondary

  • Correlate the pharmacokinetics of imatinib mesylate and its metabolites before and after randomization.

OUTLINE: This is a multicenter study. Patients are stratified according to center, site of tumor origin (stomach vs small bowel vs others), and site of metastases (liver vs abdominal cavity vs both). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo surgery of residual disease. Patients will then resume imatinib mesylate therapy according to standard of care as soon as possible after surgery (as soon as the patient restarts taking oral feeding).
  • Arm II: Patients receive imatinib mesylate therapy according to standard of care.

Patients complete quality of life questionnaires at baseline; immediately after hospital discharge (arm I only); and at 5, 11, and 23 months. Blood samples may be collected for pharmacokinetic studies.

After completion of study therapy, patients are followed up every 3 months for 5 years and then every 6 months.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • European Organization for Research and Treatment of Cancer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I
Patients undergo surgery of residual disease.
Procedure: therapeutic conventional surgery
Patients undergo surgery
ACTIVE_COMPARATOR: Arm II
Patients receive imatinib mesylate therapy according to standard of care.
Drug: imatinib mesylate
Patients receive imatinib mesylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Principal Investigator: Alessandro Gronchi, Istituto Nazionale Per Lo Studio E La Cura Dei Tumori

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

August 8, 2009

First Submitted That Met QC Criteria

August 8, 2009

First Posted (ESTIMATE)

August 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-62063
  • EU-20955
  • EUDRACT-2007-002257-23
  • NOVARTIS-EORTC-62063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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