Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
NCT ID: NCT01015339
Last Updated: 2015-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
320 participants
INTERVENTIONAL
2009-11-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cisplatin plus capecitabine
capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
cisplatin
80mg/m2, day 1 of every 3 weeks
Paclitaxel plus Capecitabine
Paclitaxel
80mg/m2 infusion,d1,d8 every 3 weeks
capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
Interventions
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Paclitaxel
80mg/m2 infusion,d1,d8 every 3 weeks
capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
cisplatin
80mg/m2, day 1 of every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Peking University
OTHER
Responsible Party
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Shen Lin
M.D.
Principal Investigators
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Lin Shen, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University, School of oncology, Department of GI oncology
Locations
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Department of GI Oncology, Peking University, School of Oncology
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ML22697
Identifier Type: -
Identifier Source: secondary_id
PAC-C
Identifier Type: -
Identifier Source: org_study_id
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