A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
Primary Purpose
Stomach Neoplasms
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-1, Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, phase I/II, Combination chemotherapy, S-1, Docetaxel
Eligibility Criteria
Inclusion Criteria:
- In phase I:histologically or cytologically confirmed advanced solid Cancer In phase II:histologically or cytologically confirmed metastatic gastric adenocarcinoma
- Age: over 18 years
- 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
- 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.
- Performance status: ECOG 0-2
- 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
- Patients should sign an informed consent
Exclusion Criteria:
- 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
- Other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Pregnant or nursing women
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- Psychiatric disorder that would preclude compliance
- Patients receiving a concomitant treatment with drugs interacting with S-1 or docetaxel: flucytosine, phenitoin, warfarin et al.
Sites / Locations
- National Cancer Center Korea
Outcomes
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
Secondary Outcome Measures
To investigate the time to progression and overall survival
Full Information
NCT ID
NCT00980382
First Posted
September 18, 2009
Last Updated
September 18, 2009
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT00980382
Brief Title
A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
Official Title
A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Stomach Neoplasms, phase I/II, Combination chemotherapy, S-1, Docetaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
S-1, Docetaxel
Intervention Description
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 Measure Information:
Title
*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 Measure Information:
Title
To investigate the time to progression and overall survival
Time Frame
During study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In phase I:histologically or cytologically confirmed advanced solid Cancer In phase II:histologically or cytologically confirmed metastatic gastric adenocarcinoma
Age: over 18 years
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
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.
Performance status: ECOG 0-2
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
Patients should sign an informed consent
Exclusion Criteria:
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
Other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
Pregnant or nursing women
Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
Psychiatric disorder that would preclude compliance
Patients receiving a concomitant treatment with drugs interacting with S-1 or docetaxel: flucytosine, phenitoin, warfarin et al.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sook Ryun Park, M.D
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Korea
City
Goyang
State/Province
Gyeonggi
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
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