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

ID: NCT02584309
Status: Recruiting
Phase: Phase 2
Start Date: February 22, 2016
First Submitted: October 12, 2015
Last Updated: February 08, 2018
Results: N/A
Sponsors & Collaborators:
Location: N/A
Conditions:
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Study Description

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

Condition or disease Intervention/treatment Phase
Phase 2

Tracking Information

First Submitted DateOctober 12, 2015
Last Update Posted DateFebruary 08, 2018
Actual Start DateFebruary 22, 2016
Anticipated Completion DateOctober 31, 2023
Actual Primary Completion DateOctober 31, 2023
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleDoxorubicin With Upfront Dexrazoxane Plus Olaratumab for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma
Official TitleA 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 TypeInterventional
Study PhasePhase 2
Estimated Enrollment
Allocation
Interventional Model
Masking
Primary Purpose
Conditions
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Recruiting
Enrollment75
Completion DateOctober 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)
- Soft tissue sarcoma for which treatment with an anthracycline is appropriate at the approval of the Principal Investigator (PI)
- 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT02584309
Other Study ID Numbers
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Not Available
Collaborators
Not Available
Investigators
Not Available