Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer: Adjuvant DXP

Study Overview
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Brief Summary
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Despite the improvement of surgical resection as primary curative treatment for gastric cancer, more than 70% of patients with stage IIIB and IV disease undergoing radical primary tumor resection relapse and die within 5 years. Therefore, there is an urgent need to further improve the treatment for gastric cancer in this population. Recently reported phase III study comparing capecitabine/cisplatin (XP) versus 5-FU/cisplatin (FP), XP showed better activity and tolerability compared with FP. To improve treatment outcomes of XP chemotherapy, the investigators performed a phase I-II study of docetaxel, capecitabine and cisplatin in advanced gastric cancer (AGC). Phase I-II study of docetaxel, capecitabine and cisplatin as first-line chemotherapy in advanced gastric cancer (Kang et al, Proc Am Soc Clin Oncol 22,328.2003). The docetaxel/capecitabine/cisplatin (DXP) chemotherapy was highly active for the 1st-line chemotherapy of AGC. These findings and experience encourages the investigators to design the adjuvant trial of DXP chemotherapy in patients with resected gastric cancer. The aim of this study is to assess the efficacy and safety of adjuvant DXP in this patient population.

Detailed Description
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Previous in phase II study of docetaxel, capecitabine and cisplatin,total 40 pts with measurable disease, median 6 cycles of chemotherapy, there were 4 confirmed complete responses (CRs) and 23 confirmed partial responses (PRs), with the overall response rate of 67.5% (95% confidence interval, 52.7   82.3) in intention-to-treat analysis. Ten patients underwent surgical resection after 4   9 cycles of chemotherapy. Four pathologic CRs were identified. With a median follow-up of 14 months (range, 1 to 28), median time to progression was 7.7 months, and median overall survival was 16.9 months. The DXP chemotherapy was highly active for the 1st-line chemotherapy of AGC (Kang et al, Proc Am Soc Clin Oncol 22,328.2003).

Official Title
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Phase 2 Study of Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer

Conditions
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Resected Advanced Gastric Cancer

Intervention / Treatment
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* Drug: docetaxel, capecitabine, cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically documented gastric adenocarcinoma Age 18 -70 Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Pathologic stage IIIB or IV complete resection (R0 resection) Exclusion Criteria: Other tumor type than adenocarcinoma R1 or R2 resection Presence of distant metastasis Gastric outlet obstruction or intestinal obstruction Evidence of gastrointestinal bleeding Other serious illness or medical conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DXP<br> | Drug: docetaxel, capecitabine, cisplatin<br>* Docetaxel 60 mg/m2 IV (day 1) every 21 days capecitabine 1,875 mg/m2/day PO, divided two (day 1-day14) every 21 days Cisplatin 60 mg/m2 IV (day 1) every 21 days<br>* Other names: docetaxel,xeloda,cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This protocol will evaluate the possible benefit of adjuvant docetaxel, capecitabine, and cisplatin combination chemotherapy in patients with resected gastric cancer pathologic stage IIIB and IV in terms of relapse free survival. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the safety profiles, patient tolerance, and overall survival in this population |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resected advanced gastric cancer stage IIIB and IV