Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Peking University

Status and phase: Unknown; Phase 3

Conditions: Advanced Gastric Cancer

Treatments: Drug: capecitabine; Drug: Paclitaxel; Drug: cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01015339

PAC-C

ML22697

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 <ULN, and CCr < 60ml/min
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Cisplatin plus capecitabine

Active Comparator group

Treatment:

Drug: cisplatin

Drug: capecitabine

Drug: capecitabine

Paclitaxel plus Capecitabine

Experimental group

Treatment:

Drug: capecitabine

Drug: capecitabine

Drug: Paclitaxel