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

NCT00813072 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2012-03-02

No results posted yet for this study

Summary

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

Conditions

  • Stomach Neoplasms
  • Esophageal Neoplasms

Interventions

DRUG

PEP02

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.

DRUG

irinotecan

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.

DRUG

docetaxel

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.

Sponsors & Collaborators

  • PharmaEngine

    lead INDUSTRY

Principal Investigators

  • David Cunningham · The Royal Marsden Hospital, London & Surrey, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • Bosnia and Herzegovina
  • Croatia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813072 on ClinicalTrials.gov