Status:
UNKNOWN
Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer
Lead Sponsor:
National Cancer Center, Korea
Collaborating Sponsors:
Seoul National University Bundang Hospital
Chungbuk National University Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess efficacy and safety of docetaxel alone, docetaxel plus cisplatin, and docetaxel plus S-1 in patients with metastatic gastric cancer after failing 1st line chemot...
Detailed Description
To date, the most commonly used first-line chemotherapies have been based on fluorouracil and/or cisplatin in patients with metastatic gastric cancer. Unfortunately, considerable proportions of patien...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed gastric adenocarcinoma with metastatic disease
- Age ≥18 years
- Eastern Cooperative Oncology Group performance status 0-2
- At least one measurable lesion as defined by RECIST
- Only one prior chemotherapy containing both S-1 or capecitabine and cisplatin for metastatic gastric cancer with documented progression of disease occurring during chemotherapy or within 6 months of completion of chemotherapy
- Adequate major organ function:
- ANC ≥1,500/mm3, Platelet ≥100,000/mm3, serum bilirubin ≤1.5 x upper limit of normal (ULN), AST/ALT ≤2.5 x ULN (≤5 x ULN if liver metastases are present), creatinine clearance ≥50 ml/min using the calculation formula or 24 hours urine collection
- Patients should sign a written informed consent before study entry
Exclusion
- Prior taxane treatment
- Major surgery or radiotherapy less than 4 weeks prior to entry
- NCI CTCAE (version 3.0) adverse events ≥grade 2 except alopecia, fatigue, and weight loss
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or inability to take oral medication
- Patients with active gastrointestinal bleeding
- Inadequate cardiovascular function
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- Other malignancy within the past 3 years except adequately treated non-melanomatous skin cancer, carcinoma in situ of the cervix, or in situ of prostate cancer Gleason≤7
- Psychiatric disorder that would preclude compliance
- Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol
- Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00980603
Start Date
November 1 2008
End Date
May 1 2011
Last Update
September 21 2009
Active Locations (4)
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1
Research Institute and Hospital, National Cancer Center Korea
Goyang, South Korea, 410-769
2
Gachon University Gil Hospital
Inchon, South Korea, 405-760
3
Chungbuk National University Hospital
Jeonju, South Korea, 361-711
4
Seoul National University Bundang Hospital
Seongnam, South Korea, 463-707