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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

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: PEP02 Drug: 5-FU Drug: LV Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. objective tumor response according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.0 [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PharmaEngine
ClinicalTrials.gov Identifier: NCT02884128    
Other Study ID Numbers: PEP0203
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms
Leucovorin
Fluorouracil
Irinotecan
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients