A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of PEP503(radio-enhancer).

There are 2 portions in this study.

• Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended injection volume of PEP503 for intratumor injection.

• Expansion phase (Part II): Following the confirmation of the recommended volume of intratumor injection, 18 additional patients will be enrolled at the recommended volume level to evaluate for efficacy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaEngine
• Treatments: Capecitabine; Fluorouracil

Criteria

Inclusion Criteria

• Histologically proven adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable disease , without evidence of distant metastases (M0)

• Distant border of the tumor must be located ≤ 10 cm from the anal verge

• Staging with MRI, transrectal ultrasound or CT-scan to confirm stage and resectability

• ECOG performance 0 - 1

• Age: 20 - 80 years old

• Adequate bone marrow, renal, and hepatic function as:

• absolute neutrophil count (ANC) ≥ 1,500/mm3

• platelet count ≥ 100,000/mm3

• total bilirubin ≤ 1.5x the upper limit of normal (ULN)

• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN

• alkaline phosphatase (ALP) ≤ 2.5 x ULN

• calculated creatinine clearance ≥ 50 mL/min, or creatinine within normal range

• All female patients of childbearing potential must have negative urine pregnancy test within the 7 days prior study treatment with PEP503. Patients must agree to use effective contraception during the study

Exclusion Criteria:

• Prior history of pelvic radiation therapy

• Hypersensitivity to fluoropyrimidine

• Uncontrolled serious medical or psychiatric illness

• Myocardial infarction or uncontrolled angor pectoris (angina) within the prior 6 months

• No more than 4 weeks since prior participation in any investigational drug study

• Major surgery within 28 days

• Other malignancy within the past 3 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum

• Cardiovascular disease that would preclude study treatment or follow-up

• Informed consent not duly signed and dated to participate in the study