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

September 18, 2009 updated by: National Cancer Center, Korea

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of
        • National Cancer Center Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. In phase I:histologically or cytologically confirmed advanced solid Cancer In phase II:histologically or cytologically confirmed metastatic gastric adenocarcinoma
  2. Age: over 18 years
  3. No prior chemotherapy or radiotherapy (including any adjuvant hemotherapy) in phase II portion Previous chemotherapy up to two regimens (including adjuvant chemotherapy) is allowed in phase I portion; patients are required to have discontinued chemotherapy, immunotherapy, and radiotherapy for at least 4 weeks before entry into phase I portion
  4. Disease status must be that of measurable disease defined as: Lesions that can be accurately measured in at least one dimension >10 mm with spiral CTscan and palpable LN (including supraclavicular LN) in physical examination.
  5. Performance status: ECOG 0-2
  6. Adequate major organ function including the following Hematopoietic function: WBC>4,000/mm3 or ANC> 2,000/mm3, Platelet count ³ 100,000/mm3Hepatic function: Bilirubin UNL (Upper normal limit), AST/ALT levels 2.5X UNL Renal function: Creatinine UNL
  7. Patients should sign an informed consent

Exclusion Criteria:

  1. Inadequate cardiovascular function: New York Heart Association class III or IV heart disease Active angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significantconduction system abnormality
  2. Other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  3. Pregnant or nursing women
  4. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
  5. Psychiatric disorder that would preclude compliance
  6. Patients receiving a concomitant treatment with drugs interacting with S-1 or docetaxel: flucytosine, phenitoin, warfarin et al.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
*phase I study:the maximum tolerated doses (MTD)of S-1 and docetaxel,recommended dose for subsequent phase II study *phase II study: evaluation of efficacy and toxicities of this new combination regimen in metastatic
Time Frame: During chemotherapy
During chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the time to progression and overall survival
Time Frame: During study period
During study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Sook Ryun Park, M.D, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

September 21, 2009

Last Update Submitted That Met QC Criteria

September 18, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-04-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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