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Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

Primary Purpose

Malignant Soft Tissue Sarcoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Propranolol Hydrochloride

Doxorubicin

About this trial

This is an interventional treatment trial for Malignant Soft Tissue Sarcoma focused on measuring efficacy, propranolol hydrochloride, sts

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

propranolol hydrochloride with Doxorubicin

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03108300

First Posted

March 16, 2017

Last Updated

February 22, 2018

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT03108300

Brief Title

Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 30, 2019 (Anticipated)

Primary Completion Date

August 30, 2020 (Anticipated)

Study Completion Date

August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Soft Tissue Sarcoma

Keywords

efficacy, propranolol hydrochloride, sts

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

propranolol hydrochloride with Doxorubicin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Propranolol Hydrochloride

Intervention Description

propranolol hydrochloride is a beta-adrenergic receptor blocker

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

Adriamycin

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression Free Survival

Description

Progression free survival (PFS) is defined as the time interval between the dates of first treatment administration and first observation of PD.

Time Frame

an average of 1 year

Secondary Outcome Measure Information:

Title

Overall Survival

Description

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.

Time Frame

an average of 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

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