Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor
PharmaEngine
Study ID
NCT00813072
Phase
PHASE2
Status
Completed

Conditions

  • Esophageal Neoplasms
  • Stomach Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PEP02 — DRUG
    120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
  • irinotecan — DRUG
    300 mg/m2, IV infusion on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
  • docetaxel — DRUG
    75 mg/m2, IV infusion for 60 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Study Details

The purpose of this study is to assess objective tumor response in the single agent treatment of PEP02, irinotecan, or docetaxel for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma

Key Dates

Start date
Nov 30, 2007
Status verified
Mar 2012
Primary completion
Jul 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
135 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1. PEP02
    liposome irinotecan
  • Active Comparator: 2. irinotecan
  • Active Comparator: 3. docetaxel

Primary Outcome Measure

objective tumor response

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