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

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ClinicalTrials.gov Identifier: NCT02465593
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
PharmaEngine

Tracking Information
First Submitted Date  ICMJE June 1, 2015
First Posted Date  ICMJE June 8, 2015
Last Update Posted Date August 31, 2018
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • safety profile /the Dose Limiting Toxicity (DLT) [ Time Frame: up to 36 months ]
    Safety as assess the safety profile and determine the Dose Limiting Toxicity (DLT) of PEP503 given as intratumor injection and activated by external beam radiation, with concurrent chemotherapy in patients with unresectable rectal cancer
  • the recommended volume (dose) [ Time Frame: up to 36 months ]
    recommended volume (dose) of PEP503 examined by given as intratumor injection and activated by external beam radiation. with concurrent chemotherapy in patients with unresectable rectal cancer
  • anti-tumor activity [ Time Frame: up to 36 months ]
    Anti-tumor activity as assessed by response rate (RR, as per RECIST 1.1) of PEP503 at the recommended volume given as intratumor injection and activated by external beam radiation, with concurrent chemotherapy in patients with unresectable rectal cancer
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02465593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer
Official Title  ICMJE A Phase Ib/II Study of PEP503 (Radioenhancer) With Radiotherapy, in Combination With Concurrent Chemotherapy for Patients With Locally Advanced or Unresectable Rectal Cancer
Brief 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.
Detailed Description The target population is composed by patients who have confirmed adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable, with tumor distal margin within 10 cm of the anal verge, with no evidence of distant metastatic disease, ECOG performance 0-1, and adequate bone marrow, renal and hepatic function.
Study Type  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • Drug: PEP503
    The volume of PEP503 to be administered is based on the baseline tumor volume of each patient. There will be 4 dose levels in Phase Ib.
    Other Name: NBTXR3
  • Drug: 5-fluorouracil
    225 mg/m2 a day, 5 days/week for 5 weeks during radiotherapy period
    Other Name: 5-FU
  • Drug: capecitabine
    825 mg/m2 BID 5 days/week for 5 weeks during the radiotherapy period
    Other Name: Xeloda
  • Procedure: surgical resection
    Approximately 8 weeks after the completion of chemoradiotherapy, surgical resection of the tumor (total mesorectal excision, TME) will be performed once the tumor become resectable.
  • Radiation: Radiotherapy
    Intensity-modulated radiation therapy (IMRT) or intensity modulated arc therapy (IMAT) of 5,000 cGy in 25 fractions (200 cGy/fraction, 5 times/week) to gross tumor and involved nodes and 4,500 cGy in 25 fractions (180 cGy/fraction, 5 times/week) to pelvis, starting at 24 hours after PEP503 injection.
Study Arms Experimental: PEP503+5-FU/capecitabine+Radiotherapy
Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
Interventions:
  • Drug: PEP503
  • Drug: 5-fluorouracil
  • Drug: capecitabine
  • Procedure: surgical resection
  • Radiation: Radiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2015)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) within normal range
    • calculated creatinine clearance ≥ 50 mL/min
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Jwa-Yuan Wang, phD 886-7-3121101 ext 5575 jayuwa@cc.kmu.edu.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02465593
Other Study ID Numbers  ICMJE PEP503-RC-1001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party PharmaEngine
Study Sponsor  ICMJE PharmaEngine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jwa-Yuan Wang, phD Kaohsiung Municipal United Hospital
PRS Account PharmaEngine
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP