Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Peking University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Peking University
Collaborator:
Roche Pharma AG
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01015339
First received: November 17, 2009
Last updated: December 28, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Gastric Cancer |
Drug: Paclitaxel Drug: capecitabine Drug: cisplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Multicenter Phase III Study Comparing Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment or Cisplatin Plus Capecitabine in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction |
Resource links provided by NLM:
Further study details as provided by Peking University:
Primary Outcome Measures:
- Progression free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tumor response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Disease control rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
- adverse evens [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 320 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Cisplatin plus capecitabine |
Drug: capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
Drug: cisplatin
80mg/m2, day 1 of every 3 weeks
|
| Experimental: Paclitaxel plus Capecitabine |
Drug: Paclitaxel
80mg/m2 infusion,d1,d8 every 3 weeks
Drug: capecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 <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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015339
Contacts
| Contact: Zhihao Lu, MD | 86-10-88196561 | pppeirain@126.com |
| Contact: Fu Chen, Bachelor | 86-10-88196561 | kimandking@163.com |
Locations
| China, Beijing | |
| Department of GI Oncology, Peking University, School of Oncology | Recruiting |
| Beijing, Beijing, China, 100142 | |
| Contact: Zhihao Lu, MD 86-10-88196561 pppeirain@126.com | |
| Principal Investigator: Shen Lin, MD | |
Sponsors and Collaborators
Peking University
Roche Pharma AG
Investigators
| Principal Investigator: | Lin Shen, MD | Peking University, School of oncology, Department of GI oncology |
More Information
No publications provided
| Responsible Party: | Shen Lin, Organization: Peking University, School of Oncology, Department of GI oncology |
| ClinicalTrials.gov Identifier: | NCT01015339 History of Changes |
| Other Study ID Numbers: | PACLIC-C, ML22697 |
| Study First Received: | November 17, 2009 |
| Last Updated: | December 28, 2009 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Capecitabine |
Cisplatin Paclitaxel Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013