Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

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

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

Study Overview

• Status: Unknown
• Conditions: Malignant Soft Tissue Sarcoma
• Intervention / Treatment: Drug: Propranolol Hydrochloride; Drug: Doxorubicin

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologic or cytologic diagnosis of malignant soft tissue sarcoma.
2. ECOG less than or equal to 2 .
3. Measurable disease according to the requirements of modified RECIST criteria.
4. Age ≥ 19 years .
5. Estimated life expectancy of at least 12 weeks .
6. 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:

1. 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).
2. Inadequate renal function (creatinine > 1.25 times UNL, creatinine clearance < 50mL/min).
3. Serious concomitant systemic disorder incompatible with the study.
4. 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).
5. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: propranolol hydrochloride with Doxorubicin; 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; propranolol hydrochloride is a beta-adrenergic receptor blocker; Drug: Doxorubicin; 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; Other Names: Adriamycin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 30, 2019
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: efficacy; propranolol hydrochloride; sts
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Propranolol; Doxorubicin
• Other Study ID Numbers: CURE002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No