Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer

• Status: Unknown status
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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 chemotherapy with cisplatin plus S-1 or capecitabine

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborators: Chungbuk National University Hospital; Gachon University Gil Medical Center; Seoul National University Bundang Hospital
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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