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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00533533

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: docetaxel, oxaliplatin	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

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 [Two years]

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. [Two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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