Close
Close

A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer

Descriptive Information
Brief Title † A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer
Official Title † A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer
Brief Summary Gastric cancer is the most common malignancy in Korea. The prognosis of unresectable gastric cancer has been improved by cytotoxic chemotherapy, but median survival rarely exceeds 1 year. New agents such as taxane, irinotecan and oxaliplatin combined with old agents such as 5-FU with or without leucovorin, doxorubicin, cisplatin showed higher response rates in phase II studies. Docetaxel as a single agents showed response rates of 17-24%, and the combination of docetaxel and cisplatin has shown a response rate of 37-56% and overall survival of 9-10.4 months. Oxaliplatin in combination with 5-FU and leucovorin(FOLFOX-6) showed an objective response rate of 50%, which included a 4% complete response. The preclinical studies, oxaliplatin has shown additive or synergistic cytotoxic properties with fluoropyrimidines, thymidylate synthase inhibitors, topoisomerase I inhibitors, microtubule inhibitors and DNA modifying/alkylating agents. The combination of docetaxel and oxaliplatin has been studied previously in the phase I setting in patients with metastatic breast and non-small cell lung cancer. The combination of docetaxel and oxaliplatin is a feasible and well tolerated regimen. Recommended doses were 75mg/m2 for docetaxel on day 1 and 70mg/m2 for oxaliplatin on day 2 without G-CSF support. The aim of this trial is to determine the dose limiting toxicities, maximum tolerated dose(MTD) and efficacy of oxaliplatin and docetaxel as combination chemotherapy in patients with advanced gastric cancer.
Detailed Description Primary objectives : To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate the overall response rate in phase II study Secondary objectives : 1. To evaluate the safety and tolerability of the treatment combination. 2. To estimate overall survival. 3. To estimate the time to progression and the duration of overall response.
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate the overall response rate in phase II study
Secondary Outcome Measure † 1) To evaluate the safety and tolerability of the treatment combination. 2) To estimate overall survival. 3) To estimate the time to progression and the duration of overall response.
Condition † Gastric Cancer
Intervention † Drugdocetaxel, oxaliplatin
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 68
Start Date † January 2006
Completion Date June 2008
Primary Completion Date March 2008
Eligibility Criteria † Inclusion Criteria: - Histologically documented gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction - 18 ≤ age ≤ 70 - ECOG performance status of 0 - 2 - At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥ 2 cm in physical examination - Previously untreated metastatic gastric cancer patients or relapsed gastric cancer patients (patients with recurrence at least 6 months from the date of last administration of adjuvant chemotherapy and/or radiation therapy with 5-FU and/or leucovorin containing regimen will be included in the study) - Written informed consent - Minimum life expectancy of 12 weeks - Adequate liver, renal, bone marrow functions as evidence by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; ASAT and/or ALAT
Gender Both
Ages 18 Years - 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Korea, Republic of
Administrative Information
NCT ID † NCT00533533
Organization ID 2005-10-047
Secondary IDs ††
Responsible Party
Study Sponsor † Samsung Medical Center
Collaborators ††
Investigators † Principal Investigator: Young Suk Park, M.D., Ph.D., Samsung Medical Center, Seoul, KOREA
Information Provided By
Verification Date November 2006
First Received Date † September 19, 2007
Last Updated Date January 12, 2009
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
Find a Clinical Trial
Trending videos
by Abidemi Uruejoma
29,263 views
by Christine DuBois
23,808 views
by Abidemi Uruejoma
21,632 views
Free Newsletter