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

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00533533

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer	Drug: docetaxel, oxaliplatin	Phase I Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Oxaliplatin Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate the overall response rate in phase II study [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	68
Study Start Date:	January 2006
Study Completion Date:	June 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Oxaliplatin will be administered in combination with docetaxel as a first-line chemotherapy in advanced gastric cancer patients. Each cycle is repeated every 3 weeks.

Docetaxel Oxaliplatin Level 1 60 mg/m2/day 1 100 mg/m2/day 1 Level 2 75 mg/m2/day 1 100 mg/m2/day 1 Level 3 75 mg/m2/day 1 130 mg/m2/day 1

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 :

To evaluate the safety and tolerability of the treatment combination.
To estimate overall survival.
To estimate the time to progression and the duration of overall response.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 < 3 UNL; serum creatinine ≤ 1.5 ULN

Exclusion Criteria:

Any other malignancies within the past 5 years except skin basal cell cancer or CIS of cervix
Serious comorbid diseases
Pregnancy or lactation
Previous history of drug allergy to one of the drugs in the study regimen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533533

Locations

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Young Suk Park, M.D., Ph.D.

Samsung Medical Center, Seoul, KOREA

More Information

Publications:

Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J. Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer. 1994 Aug;70(2):380-3.

Roth AD, Maibach R, Martinelli G, Fazio N, Aapro MS, Pagani O, Morant R, Borner MM, Herrmann R, Honegger H, Cavalli F, Alberto P, Castiglione M, Goldhirsch A. Docetaxel (Taxotere)-cisplatin (TC): an effective drug combination in gastric carcinoma. Swiss Group for Clinical Cancer Research (SAKK), and the European Institute of Oncology (EIO). Ann Oncol. 2000 Mar;11(3):301-6.

Kouroussis C, Agelaki S, Mavroudis D, Kakolyris S, Androulakis N, Kalbakis K, Souglakos J, Mallas K, Bozionelou V, Pallis A, Adamtziki H, Georgoulias V. A dose escalation study of docetaxel and oxaliplatin combination in patients with metastatic breast and non-small cell lung cancer. Anticancer Res. 2003 Jan-Feb;23(1B):785-91.

Louvet C, Andre T, Tigaud JM, Gamelin E, Douillard JY, Brunet R, Francois E, Jacob JH, Levoir D, Taamma A, Rougier P, Cvitkovic E, de Gramont A. Phase II study of oxaliplatin, fluorouracil, and folinic acid in locally advanced or metastatic gastric cancer patients. J Clin Oncol. 2002 Dec 1;20(23):4543-8.

Responsible Party:	Samsung Medical Center ( Young Suk Park )
Study ID Numbers:	2005-10-047
Study First Received:	September 19, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00533533 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:

Docetaxel,Oxaliplatin
Phase I/II study
Advanced gastric cancer
First line treatment
Advanced gastric cancer with measurable disease

Study placed in the following topic categories:

Docetaxel
Oxaliplatin
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer

Additional relevant MeSH terms:

Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Pharmacologic Actions
Docetaxel
Neoplasms
Oxaliplatin

Neoplasms by Site
Digestive System Diseases
Stomach Diseases
Stomach Neoplasms
Therapeutic Uses
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009