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A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma

NCT00980382 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2009-09-21

No results posted yet for this study

Summary

This study is an open-label, single center, nonrandomized study, consisting of a dose-escalating phase I study in advanced solid cancer and a subsequent phase II study in metastatic gastric cancer. In phase I study, we aim to determine the MTD and the recommended dose of S-1 combined with docetaxel given every 3 weeks. Dose level and escalating schedule are followings

* S-1(level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14)
* Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) mixed in d5w 200 ml iv over 60 min: Days 1, 8with dexamethasone 8 mg po q 12hr for 3 days (total 6 doses: D0-2)and parenteral pheniramine maleate 1 ample (45.5mg) before docetaxel

Conditions

  • Stomach Neoplasms

Interventions

DRUG

S-1, Docetaxel

* Phase I study * S-1 (level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14 * Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) iv : Days 1, 8 * Phase II study * S-1 (80mg/m2/day) q 12 hours po Days 1-14 * Docetaxel (35 mg/m2) iv : Days 1, 8

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Sook Ryun Park, M.D · National Cancer Center, Korea

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • South Korea

Study Locations

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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 NCT00980382 on ClinicalTrials.gov