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Status:

ACTIVE_NOT_RECRUITING

Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Gastrointestinal Stromal Tumor

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This phase II trial is studying how well sorafenib works in treating patients with malignant gastrointestinal stromal tumor that progressed during or after previous treatment with imatinib mesylate an...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the objective response rate of patients with imatinib and sunitinib-resistant malignant gastrointestinal stromal tumor who are treated with BAY 43-9006. SECONDARY...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed gastrointestinal stromal tumor
  • Not amenable to curative surgery
  • Kit-expressing tumor
  • Disease progression (i.e., new lesion or 20% increase in unidimensional tumor size) on or after treatment with imatinib mesylate and sunitinib malate
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
  • Only site of measurable disease must be outside of previously irradiated area
  • No known brain metastases
  • Performance status - ECOG 0-2
  • More than 3 months
  • Absolute neutrophil count \> 1,500/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Bilirubin normal
  • AST and ALT \< 2.5 times upper limit of normal
  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance \> 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No evidence of bowel perforation or obstruction
  • No prior angiogenesis inhibitors
  • No immunotherapy after the last dose of imatinib mesylate or sunitinib malate
  • No chemotherapy or chemoembolization therapy after the last dose of imatinib mesylate or sunitinib malate
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 14 days since prior imatinib mesylate or sunitinib malate
  • No prior sorafenib
  • No prior inhibitors of MAPK-signaling intermediates
  • No other investigational agent after the last dose of imatinib mesylate or sunitinib malate
  • Concurrent anticoagulation therapy with warfarin allowed provided the following criteria are met:
  • On a therapeutic stable warfarin dose
  • INR ≤3
  • No active bleeding or pathologic condition that confers a high risk of bleeding
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent administration of any of the following:
  • Enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital)
  • Hypericum perforatum (St. John's wort)
  • Rifampin
  • No other concurrent anticancer agents or therapies

Exclusion

    Key Trial Info

    Start Date :

    September 14 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 19 2026

    Estimated Enrollment :

    38 Patients enrolled

    Trial Details

    Trial ID

    NCT00265798

    Start Date

    September 14 2005

    End Date

    March 19 2026

    Last Update

    August 20 2025

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    City of Hope Comprehensive Cancer Center

    Duarte, California, United States, 91010

    2

    University of California Davis Comprehensive Cancer Center

    Sacramento, California, United States, 95817

    3

    University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, United States, 60637

    4

    Decatur Memorial Hospital

    Decatur, Illinois, United States, 62526