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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00980382
First received: September 18, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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

Condition Intervention Phase
Stomach Neoplasms
 Drug: S-1, Docetaxel
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • *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 ]

Secondary Outcome Measures:
  • To investigate the time to progression and overall survival [ Time Frame: During study period ]

Enrollment: 85
Study Start Date: September 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980382

Locations
Korea, Republic of
National Cancer Center Korea
Goyang, Gyeonggi, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Sook Ryun Park, M.D National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Sook Ryun Park/MD, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00980382     History of Changes
Other Study ID Numbers: NCCCTS-04-107
Study First Received: September 18, 2009
Last Updated: September 18, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
Stomach Neoplasms
phase I/II
Combination chemotherapy
S-1
Docetaxel

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013