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Study of Cetuximab Plus P-HDFL for the First-Line Treatment of Advanced Gastric Cancer

NCT00384878 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2009-02-09

No results posted yet for this study

Summary

The primary end point of the study is confirmed objective response rate (complete response \[CR\] and partial response \[PR\]). A response rate of 80 percent for cetuximab plus cisplatin and weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin (P-HDFL) chemotherapy is assumed. The Simon two-stage design will be used for P1 - P0 = 0.20. The response rates of interest are P0 = 60% and P1 = 80%. The investigators will reject cetuximab plus P-HDFL chemotherapy if the response rate is 8/13 at the first stage, and will reject the cetuximab plus P-HDFL chemotherapy if the response rate is 25/35 at the second stage. If there are more than 8 responses in 13 patients in the first stage, the study will continue to a total of 35 patients in the second stage. If there are more than 25 responses in 35 patients in the second stage, this treatment will be acceptable with a p-value of 0.05 and of 0.20. Evaluable patients for response will be those who received at least 4 doses of cetuximab (i.e. one cycle of protocol treatment). All enrolled patients will be subjected to toxicity evaluations.

The primary end point of the study is confirmed objective response rates (by RECIST, Response Evaluation Criteria in Solid Tumors). The secondary end points of the study are progression-free survival, overall survival, and treatment-related toxicities.

The analysis of response to treatment will be restricted to the eligible patients with at least one measurable lesion. The safety analysis will be restricted to the patients who received at least one cycle of the administered chemotherapy. The time-to-event end points will be estimated using the method of Kaplan and Meier and based on the intent-to-treat principle. Overall survival will be defined as the time interval between the date of study entry and the date of death. Progression-free survival will be defined as the time interval between the date of study entry and the date of disease progression or death, whichever occurred first. Duration of response will be defined as the time interval between the date of initial objective response and the date of disease progression, which is only for responders. If the event is not yet observed at the time of the last record, the patient will be censored at that time point.

Conditions

  • Stomach Neoplasms

Interventions

DRUG

Cetuximab, Cisplatin,5-Fluorouracil,Leucovorin

Sponsors & Collaborators

  • Far Eastern Memorial Hospital

    lead OTHER

Principal Investigators

  • Kun Huei Yeh, Ph.D. · Far Eastern Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00384878 on ClinicalTrials.gov