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

Gastric Cancer Clinical Trial

— DO for AGC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533533
• Other study ID #: 2005-10-047
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 19, 2007
• Last updated: January 12, 2009
• Start date: January 2006
• Est. completion date: June 2008

Study information

• Verified date: November 2006
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• docetaxel, oxaliplatin
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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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 an — View Citation

Louvet C, André T, Tigaud JM, Gamelin E, Douillard JY, Brunet R, François 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 — View Citation

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 G — View Citation

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):3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate the overall response rate in phase II study		Two years	Yes
Secondary	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.		Two years	Yes