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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980382
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : September 21, 2009
Information provided by:
National Cancer Center, Korea

Brief 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

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Drug: S-1, Docetaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
Study Start Date : September 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Docetaxel

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

Primary Outcome Measures :
  1. *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 :
  1. To investigate the time to progression and overall survival [ Time Frame: During study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00980382

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

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Responsible Party: Sook Ryun Park/MD, National Cancer Center, Korea Identifier: NCT00980382     History of Changes
Other Study ID Numbers: NCCCTS-04-107
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009
Keywords provided by National Cancer Center, Korea:
Stomach Neoplasms
phase I/II
Combination chemotherapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action