Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

• Status: Unknown status
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Doxorubicin; Liposomal doxorubicin; Propranolol

Criteria

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