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A Phase II Study of BAY 43-9006 for Imatinib- and Sunitinib-Resistant Malignant Gastrointestinal Stromal Tumor


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumor

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Trial Information

A Phase II Study of BAY 43-9006 for Imatinib- and Sunitinib-Resistant Malignant Gastrointestinal Stromal Tumor


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (partial response [PR] or complete response [CR])

Outcome Description:

Objective response will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria from the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is documented. 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. A 5% response rate precludes further study whereas a 20% response rate would indicate that further investigation of the treatment is warranted.

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Hedy Kindler

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00116

NCT ID:

NCT00265798

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470