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Trial record 3 of 9 for:    "pharmaengine" [Exact]

A Study of PEP02 in Combination With 5-fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02884128
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
PharmaEngine

Tracking Information
First Submitted Date  ICMJE August 12, 2016
First Posted Date  ICMJE August 30, 2016
Last Update Posted Date August 30, 2016
Study Start Date  ICMJE January 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
Dose limiting toxicity (DLT) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
objective tumor response according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.0 [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PEP02 in Combination With 5-fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Tumors
Official Title  ICMJE A Multi-Center, Open-Label Phase I Dose-Escalation Study of PEP02 in Combination With 5-fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Tumors
Brief Summary This trial is a multi-center, open-label, phase I, dose escalation study of PEP02 (liposomal encapsulated irinotecan) in combination with 5-FU and LV in patients with advanced solid tumors.
Detailed Description In this study, the initial starting dose of PEP02 is 60 mg/m2, and was escalated by increments of 20 mg/m2 between dose levels. 5-FU and LV was given as 24-hour infusion via an implanted central venous catheter, with dose fixed at 2000 mg/m2 and 200 mg/m2, respectively. PEP02 was administered on Day 1; 5-FU/LV was started after the end of PEP02 infusion on Day 1 and also on Day 8. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE
  • Drug: PEP02
    PEP02 was administered on Day 1. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.
    Other Name: liposomal irinotecan
  • Drug: 5-FU
    5-FU/LV were started after the end of PEP02 infusion on Day 1 and also on Day 8. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.
    Other Name: Fluorouracil
  • Drug: LV
    5-FU/LV were started after the end of PEP02 infusion on Day 1 and also on Day 8. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.
    Other Name: Leucovorin
Study Arms  ICMJE Experimental: PEP02 + 5-FU/LV
The initial starting dose of PEP02 is 60 mg/m2, and was escalated by increments of 20 mg/m2 between dose levels. 5-FU and LV were given as 24-hour infusion via an implanted central venous catheter, with dose fixed at 2000 mg/m2 and 200 mg/m2, respectively. PEP02 was administered on Day 1; 5-FU/LV was started after the end of PEP02 infusion on Day 1 and also on Day 8.
Interventions:
  • Drug: PEP02
  • Drug: 5-FU
  • Drug: LV
Publications * Chiang NJ, Chao TY, Hsieh RK, Wang CH, Wang YW, Yeh CG, Chen LT. A phase I dose-escalation study of PEP02 (irinotecan liposome injection) in combination with 5-fluorouracil and leucovorin in advanced solid tumors. BMC Cancer. 2016 Nov 21;16(1):907.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2016)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed solid tumor which was locally advanced or metastatic and had failed to standard chemotherapy or no standard treatment was available
  • ECOG performance status 0 or 1
  • With normal organ and marrow function

Exclusion Criteria:

  • Have had major surgery, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from toxicities due to previous treatment
  • With known or suspicious primary or secondary brain tumors
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PEP02, 5-FU or leucovorin
  • HBsAg+ or anti-HCV+ patients with splenomegaly (defined as spleen size > 11 cm in CT scan)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, and history of symptomatic congestive heart failure of Functional Class II or more (New York Heart Association) and ischemic heart diseases (i.e. myocardial infarction or angina pectoris), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breast feeding females (a pregnancy test must be performed on all females who are of child-bearing potential before entering the study and the result must be negative)
  • Had received irinotecan treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02884128
Other Study ID Numbers  ICMJE PEP0203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PharmaEngine
Study Sponsor  ICMJE PharmaEngine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PharmaEngine
Verification Date August 2016

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