Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 14-005565
    • Rochester, Minnesota: 14-005565
    NCT ID: NCT02066181
    Sponsor Protocol Number: A091105

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 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:
    • 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
    • Progression by radiographic imaging (10% increase in size by RECIST v1.1 within 6 months of registration)
    • Patients with symptomatic disease which meets the following criteria Brief Pain Inventory (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
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Patients who are pregnant or nursing are not eligible
  • No patients with a history of cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); active coronary artery disease (CAD) (myocardial infarction or unstable angina within 6 months prior to study entry)
  • No patients with inadequately controlled hypertension (defined as a blood pressure of >= 150 mmHg systolic and/or >= 90 mmHg diastolic), or any prior history of hypertensive crisis or hypertensive encephalopathy
  • No patients with clinically significant gastrointestinal (GI) bleeding or bleeding diathesis within 30 days prior to registration
  • Absolute neutrophil count >= 1,500/mm^3
  • Hemoglobin >= 8 g/dl
  • Platelets >= 75,000/mm^3
  • Total bilirubin =< 1.5 x upper limits of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])/serum glutamate pyruvate transaminase (SGPT) (aspartate aminotransferase [ALT]) =< 1.5 x ULN
  • Calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault equation

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Scott Okuno, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Scott Okuno, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20143787

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