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Sponsored by: |
Nanjing Sike Pharmaceutical Co., Ltd. |
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Information provided by: | Nanjing Sike Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00639522 |
The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.
Condition | Intervention | Phase |
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Gastric Carcinoma |
Drug: Liposomal paclitaxel and capecitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma. |
Estimated Enrollment: | 18 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Liposomal paclitaxel and capecitabine
Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2、185mg/m2、195mg/m2、 200mg/m2、205mg/m2 and so on ,at the first day of chemotherapy. Capecitabine will be given on d1 to d14 with the dose of 185mg/m2、200mg/m2 or d8 to d21 with the dose of 175mg/m2、195mg/m2、205mg/m2 .Cycle duration will be 21 days. Each patient will receive 2 cycles of therapy. Only in the first cycle blood samples will be taken on 16 points in 48 hours after the infusion of liposomal paclitaxel.
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The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in Chinese patients with advanced gastric carcinoma.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jinwan Wang, Doctor | 086-010-87788842 | hsunyk@tom.com |
Contact: Chi Yihebali, Doctor | 086-010-87788118 | yihebalichi@yahoo.com.cn |
China | |
Cancer Hospital,Chinese Academy of Medical Science | Recruiting |
Beijing, China, 100021 | |
Contact: Jinwan Wang, Doctor 086-010-87788842 hsunyk@tom.com | |
Contact: Chi Yihebali, Doctor 086-010-87788118 yihebalichi@yahoo.com.cn | |
Principal Investigator: Jinwan Wang, Doctor |
Principal Investigator: | Jinwan Wang, Doctor | Cancer Hospital, Chinese Academy of Medical Science |
Responsible Party: | Cancer Institute and Hospital,Chinese Academy of Medical Science ( Prof. Jinwan Wang ) |
Study ID Numbers: | LPS-GC-01-2008, NO |
Study First Received: | March 14, 2008 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00639522 History of Changes |
Health Authority: | China: Ministry of Health |
Liposomal paclitaxel Maximum tolerated dose Pharmacokinetics Gastric carcinoma |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Antimitotic Agents Carcinoma Digestive System Diseases Stomach Diseases |
Paclitaxel Stomach Neoplasms Tubulin Modulators Gastrointestinal Neoplasms Stomach Cancer Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Mitosis Modulators Antimitotic Agents Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Paclitaxel Therapeutic Uses Stomach Neoplasms Tubulin Modulators Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |