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Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.

NCT00209612 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-02-17

No results posted yet for this study

Summary

A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using CPT-11 and Paclitaxel in pre-treated patients with metastatic gastric cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.

Conditions

Interventions

DRUG

Taxol

Day1,15 X mg/m2, IV (in the vein)

DRUG

Campt, Topotesin

Day1,15 Y mg/m2, IV (in the vein)

Sponsors & Collaborators

  • Hokkaido University Hospital

    collaborator OTHER

  • Hokkaido Gastrointestinal Cancer Study Group

    lead OTHER

Principal Investigators

  • Masahiro Asaka, MD, PhD · Hokkaido Gastrointestinal Cancer Study Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2008-11-30
Completion
2009-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

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 NCT00209612 on ClinicalTrials.gov