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Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03108300
Recruitment Status : Not yet recruiting
First Posted : April 11, 2017
Last Update Posted : February 23, 2018
Information provided by (Responsible Party):
Ahmed Nagy, Ain Shams University

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Malignant Soft Tissue Sarcoma Drug: Propranolol Hydrochloride Drug: Doxorubicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Propranolol Hydrochloride Combined With Anthracyclin Based Chemotherapy in the Treatment of Metastatic Soft Tissue Sarcoma
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2021

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 Name: Adriamycin

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: an average of 1 year ]
    Progression free survival (PFS) is defined as the time interval between the dates of first treatment administration and first observation of PD.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: an average of 3 years ]
    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.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Ahmed Nagy, Principal Investigator, Ain Shams University Identifier: NCT03108300     History of Changes
Other Study ID Numbers: CURE002
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Nagy, Ain Shams University:
propranolol hydrochloride
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents