Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

Study Overview
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Brief Summary
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Fifty patients with pathological proof of malignant soft tissue sarcoma will receive Anthracyclin based chemotherapy combined with propranolol 40 mg twice daily. The primary end point : To assess Progression Free Survival (PFS) The secondary end points : To assess Overall Survival (OS) and Toxicity Profile

Official Title
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The Use of Propranolol Hydrochloride Combined With Anthracyclin Based Chemotherapy in the Treatment of Metastatic Soft Tissue Sarcoma

Conditions
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Malignant Soft Tissue Sarcoma

Intervention / Treatment
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* Drug: Propranolol Hydrochloride
* Drug: Doxorubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic or cytologic diagnosis of malignant soft tissue sarcoma. ECOG less than or equal to 2 . Measurable disease according to the requirements of modified RECIST criteria. Age ≥ 19 years . Estimated life expectancy of at least 12 weeks . Adequate bone marrow reserve (white blood cells [WBC] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL). Exclusion Criteria: Inadequate liver function (bilirubin > 1.5 times upper normal limit [UNL] and alanine transaminase [ALT] or aspartate transaminase [AST] > 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases). Inadequate renal function (creatinine > 1.25 times UNL, creatinine clearance < 50mL/min). Serious concomitant systemic disorder incompatible with the study. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence). Pregnancy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propranolol hydrochloride with Doxorubicin<br>The patients suffering from metastatic soft tissue sarcoma will receive doxorubicin 60mg per square meter of body surface area every 21 days combined with propranolol hydrochloride 40mg twice daily | Drug: Propranolol Hydrochloride<br>* propranolol hydrochloride is a beta-adrenergic receptor blocker<br>Drug: Doxorubicin<br>* Doxorubicin is a chemotherapy which will be injected by a dose 60 mg per meter square of body surface area to be repeated every 21days<br>* Other names: Adriamycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Progression free survival (PFS) is defined as the time interval between the dates of first treatment administration and first observation of PD. | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall Survival (OS) is defined as the time from the date of the first treatment administration to the date of death due to any cause. | an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, propranolol hydrochloride, sts