Page 12 - Delaware Medical Journal - November 2015
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CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
ALLIANCE A091105: A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive
Fibromatosis (DT/DF) The objectives of the trial are:
Primary Objective:
To compare the progression-free survival (PFS) rates of patients with DT/DF who receive either sorafenib or placebo using a double- blinded randomized phase III study.
Secondary Objectives:
1. To assess toxicity.
2. To assess time to surgical intervention.
3. To assess tumor response rates and survival.
Correlative Companion Study Objectives:
1. To evaluate changes in MRI T2 to predict (or correlate) with a biological effect such as tumor growth (by RECIST v1.1), and pain palliation.
2. The mechanism of action of sorafenib in DT/DF remains unknown. In patients consenting to undergo the paired tumor biopsies
selected interrogation of key pathways by Western blot and RT-PCR.
3. To collect archival tissue, baseline (tumor, blood) and day 8 (tumor, blood) specimens for basic science research (A091105-
ST1).
4. To assess patient-reported adverse events and quality of life (QOL) as measured by the PRO-CTCAE and the single-item
overall LASA (A091105-HO1).
5. To assess pain palliation measured by the “worst pain” item of the Brief Pain Inventory Short Form (A091105-HO1).
Eligibilty:
•
• Patients may have been treated with locoregional therapies such as major surgery, radiation, radiofrequency ablation,
cryosurgery, cytotoxic, biologic (antibody), immune or experimental therapy, tyrosine kinase inhibitors, hormone inhibitors or
NSAIDs provided this has been completed at least 4 weeks prior to registration.
• Chronic concomitant treatment of CYP3A4-inducers, or therapeutic doses of anti-coagulants is not permitted.
• Must have measureable disease.
• Patients have to meet one of the following criteria to be eligible:
1. Disease determined unresectable or entailing unacceptably morbid surgery based on 1 or more of the following characteristics:
• Multifocal disease
• Disease in which there is involvement or inadequate plane from: neurovascular bundle, bone, skin, or viscera
• Large size in relationship to location OR multi-compartment involvement
2. Progression by radiographic imaging (10% increase in size by RECIST v1.1 within 6 months).
3. Patients with symptomatic disease which meets the following criteria BPI score greater than or equal to 3 AND one of the
following:
• Inability to control pain with NSAIDs and considering addition of narcotics OR
• >30% increase in current use of narcotics OR
• Addition of a new opioid narcotic
Treatment:
Patients will be randomized to receive either sorafenib 400 mg PO (two 200 mg pills) once daily or placebo (two pills) once daily until progression of disease, or unacceptable toxicity. Patients who progress and were found to be on placebo may
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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