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Doxorubicin With Upfront Dexrazoxane Plus Olaratumab for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma

Descriptive Information
Brief Title † Doxorubicin With Upfront Dexrazoxane Plus Olaratumab for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma
Official Title † A Non-Inferiority Study of Doxorubicin With Upfront Dexrazoxane Plus Olaratumab for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma
Brief Summary The purpose of this research study is to look at whether giving a drug called dexrazoxane plus olaratumab with standard of care doxorubicin affects the progression of the disease. Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and severity of disease of the heart muscle (which can be caused by doxorubicin).
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Progression-free survival (PFS) (Arm 1 only)
Secondary Outcome Measure † Cardiac-related mortality
Condition † Sarcoma, Soft Tissue Soft Tissue Sarcoma Undifferentiated Pleomorphic Sarcoma Leiomyosarcoma Liposarcoma Synovial Sarcoma Myxofibrosarcoma Angiosarcoma Fibrosarcoma Malignant Peripheral Nerve Sheath Tumor Epithelioid Sarcoma
Intervention † DrugDexrazoxane
Study Arms / Comparison Groups Arm 1: dexrazoxane & standard of care doxorubicin + olaratumab Dexrazoxane will be given intravenously on an outpatie2. -nt basis over 15 minutes on each day that doxorubicin is given. Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle. Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2. Olaratumab is typically given on Days 1 and 8 of 21-day cycle at a dose of 15 mg/kg. Both doxorubicin and olaratumab are being given as routine care; their administration is not dictated per protocol. Arm 2: control (standard of care doxorubicin + olaratumab) Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. --Olaratumab is typically given on Days 1 and 8 of 21-day cycle at a dose of 15 mg/kg. Both doxorubicin and olaratumab are being given as routine care; their administration is not dictated per protocol. The last 10 patients enrolled after completion of enrollment to Arm 1 (dexrazoxane & standard of care doxorubicin) will be enrolled to Arm 2 (control arm - standard of care doxorubicin only)
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 73
Start Date † February 22, 2016
Completion Date October 31, 2023
Primary Completion Date October 31, 2023
Eligibility Criteria † Inclusion Criteria: - Histologically confirmed grade 2 or 3 soft tissue sarcoma that is unresectable or metastatic. Surgery for primary or metastatic disease after chemotherapy following a response is allowed. Patients with the following tumor types are eligible: - Undifferentiated pleomorphic sarcoma - Leiomyosarcoma - Malignant fibrous histiocytoma - Liposarcoma (myxoid/round cell, pleomorphic or dedifferentiated) - Synovial sarcoma - Myxofibrosarcoma - Angiosarcoma - Fibrosarcoma - Malignant peripheral nerve sheath tumor - Epithelioid sarcoma - Unclassified high-grade sarcoma (not otherwise specified) - Measurable disease according to RECIST 1.1; that is, measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam. - Planning to initiate treatment with doxorubicin (starting dose 75 mg/m2) and olaratumab (starting dose of 15 mg/kg) as routine care. - Prior adjuvant chemotherapy with gemcitabine and/or docetaxel/paclitaxel is allowed. - At least 18 years of age. - ECOG performance status of 0 or 1 - Adequate organ function defined as: - Leukocytes ≥ 3,000/mcL - Absolute neutrophil count ≥ 1,500/mcl - Platelets ≥ 100,000/mcl - Total bilirubin ≤ 1.5 x IULN - AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN - Creatinine ≤ IULN OR Creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal - Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. - Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: - Myocardial infarction within the past 12 months, or stable or unstable angina. - Systolic heart failure defined as left ventricular ejection fraction ≤ 45%. - Symptomatic valvular heart disease. - Prior chemotherapy for advanced or metastatic disease. - Known brain metastases. - Prior or second primary malignancies within the last two years (except carcinoma in situ of the cervix, non-metastatic prostate cancer, or basal cell or squamous cell carcinoma of the skin which were treated with local resection only; prior adjuvant androgen deprivation therapy in the case of prostate cancer is permitted, but current adjuvant androgen deprivation therapy is not). - Currently receiving any investigational agents. - A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dexrazoxane or other agents used in the study. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry. - Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with dexrazoxane. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. - Prior treatment with anthracyclines.
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Brian A Van Tine, M.D., Ph.D., 314-747-8475, bvantine@wustl.edu
Location Countries † United States
Administrative Information
NCT ID † NCT02584309
Organization ID 201510049
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Washington University School of Medicine
Collaborators ††
Investigators † Principal Investigator: Brian A Van Tine, M.D., Ph.D., Washington University School of Medicine
Information Provided By
Verification Date February 2017
First Received Date † October 12, 2015
Last Updated Date February 14, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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