Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Desmoid Fibromatosis

In brief

This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. \[Funding Source - FDA OOPD\]

Key facts

Study ID

NCT02066181

Run by

National Cancer Institute (NCI)

People needed

87

Starts

2014-03-21

Expected to finish

2022-12-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have confirmation of DT/DF by local pathologist prior to registration
• Patients may have been treated with locoregional therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery provided this has been completed at least 4 weeks prior to registration and recovered from therapy related toxicity to less than CTCAE grade 2
• Patients may have been treated with cytotoxic, biologic (antibody), immune or experimental therapy, tyrosine kinase inhibitors, hormone inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) provided this has been completed at least 4 weeks prior to registration (6 weeks for mitomycin and nitrosoureas) and recovered from any therapy related toxicity to less than CTCAE grade 2
• Patients with prior or current treatment of sorafenib are excluded
• No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; please note that drugs that strongly induce or inhibit cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or are associated with a risk of torsades are not allowed; chronic concomitant treatment of CYP3A4 inducers is not allowed (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's wort); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the following drugs are strong inhibitors of CYP3A4 and are not allowed during the treatment with sorafenib:
• Boceprevir
• Indinavir
• Nelfinavir
• Lopinavir/ritonavir
• Saquinavir
• Telaprevir
• Ritonavir
• Clarithromycin
• Conivaptan
• Itraconazole
• Ketoconazole
• Mibefradil
• Nefazodone
• Posaconazole
• Voriconazole
• Telithromycin
• Drugs with possible or conditional risk of torsades should be used with caution knowing that sorafenib could prolong the QT interval
• Chronic daily NSAID use as treatment for controlling desmoid tumors is not allowed, and should be stopped >= 3 days prior to registration; NSAIDS are allowed when used for desmoid tumor-related pain or for symptoms that are unrelated to desmoid disease (eg. headache, arthritis)
• Patients must have measurable disease
• Patients have to meet one of the following criteria to be eligible:

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• PCR Oncology — Arroyo Grande, California, United States
• Yale University — New Haven, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Gynecologic Oncology LLC — Newark, Delaware, United States
• Delaware Clinical and Laboratory Physicians PA — Newark, Delaware, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Beebe Health Campus — Rehoboth Beach, Delaware, United States
• TidalHealth Nanticoke / Allen Cancer Center — Seaford, Delaware, United States
• Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• John B Amos Cancer Center — Columbus, Georgia, United States
• Low Country Cancer Care — Savannah, Georgia, United States
• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia, United States
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Straub Clinic and Hospital — Honolulu, Hawaii, United States
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States
• Hawaii Cancer Care Inc-Liliha — Honolulu, Hawaii, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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