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

Primary Purpose

Gastrointestinal Stromal Tumor

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sorafenib Tosylate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • University of California Davis Comprehensive Cancer Center
  • University of Chicago Comprehensive Cancer Center
  • Decatur Memorial Hospital
  • Central Illinois Hematology Oncology Center
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (sorafenib tosylate)

Arm Description

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Objective Response Rate
Objective response (complete response (CR)+ partial response (PR)) will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Computed Tomography (CT) scans for disease reassessment will be obtained pre-therapy and every 8 weeks. In addition to a baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of objective response.

Secondary Outcome Measures

Progression-free Survival
Progression-free survival will be defined as time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death, whichever comes first. CT scans for disease reassessment will be obtained pre-therapy and every 8 weeks.
Overall Survival
Overall survival will be defined as time from the start of treatment until death from any cause.

Full Information

First Posted
December 14, 2005
Last Updated
August 23, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00265798
Brief Title
Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate
Official Title
A Phase 2 Study of BAY 43-9006 for Imatinib- and Sunitinib Resistant Gastrointestinal Stromal Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2005 (Actual)
Primary Completion Date
February 11, 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 and sunitinib malate. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
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 OBJECTIVES: I. To determine the toxicity experienced by patients with imatinib and sunitinib -resistant malignant gastrointestinal stromal tumor who are treated with BAY 43-9006. II. To determine progression-free survival and overall survival in patients with imatinib and sunitinib -resistant malignant gastrointestinal stromal tumor who are treated with BAY 43-9006. TERTIARY OBJECTIVES: I. To examine if mutational status of KIT and PDGFA in patients with imatinib- and sunitinib resistant malignant gastrointestinal stromal tumor correlate with response to BAY 43-9006. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with imatinib mesylate and sunitinib malate (imatinib mesylate- and sunitinib malate-responsive disease vs primary imatinib mesylate- and sunitinib malate-refractory disease). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (sorafenib tosylate)
Arm Type
Experimental
Arm Description
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Sorafenib Tosylate
Other Intervention Name(s)
BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
Objective response (complete response (CR)+ partial response (PR)) will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Computed Tomography (CT) scans for disease reassessment will be obtained pre-therapy and every 8 weeks. In addition to a baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of objective response.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival will be defined as time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death, whichever comes first. CT scans for disease reassessment will be obtained pre-therapy and every 8 weeks.
Time Frame
Up to 5 years
Title
Overall Survival
Description
Overall survival will be defined as time from the start of treatment until death from any cause.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedy L Kindler
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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