Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
Conditions
Advanced Gastric Cancer
Conditions: official terms
Adenocarcinoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Paclitaxel Type: Drug
Name: capecitabine Type: Drug
Name: capecitabine Type: Drug
Name: cisplatin Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to investigate whether Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Having signed informed consent

- Age≥ 18 years old

- Histologically confirmed gastric adenocarcinoma

- Unresectable recurrent or metastatic disease

- Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months

- Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.

- Measurable disease according to the RECIST criteria

- Karnofsky performance status ≥60

- Life expectancy of ≥2 month

- No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks

- ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)

- Serum albumin level ≥3.0g/dL

- Serum AKP < 2.5 times ULN

- Serum creatinine
- Bilirubin level < 1.5 ULN

- WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

- Brain metastasis (known or suspected)

- Previous systemic therapy for metastatic gastric cancer

- Inability to take oral medication

- Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy

- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry

- Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.

- Allergic constitution or allergic history to protium biologic product or any investigating agents.

- Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.

- Pregnancy or lactation period

- Any investigational agent within the past 28 days

- Other previous malignancy within 5 year, except non-melanoma skin cancer

- Previous adjuvant therapy with capecitabine+platinum,

- Pre-existing neuropathy>grade 1

- Legal incapacity
Location
Department of GI Oncology, Peking University, School of Oncology
Beijing, Beijing, China
Status: Recruiting
Contact: Zhihao Lu, MD - 86-10-88196561 - pppeirain@126.com
Start Date
November 2009
Completion Date
August 2015
Sponsors
Peking University
Source
Peking University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page