MedDataX Logo

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

NCT ID: NCT00275951

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The clinical efficacy (confirmed objective response rates, progression-free survival, overall survival), and treatment-related toxicities of this novel regimen will be examined as the first-line treatment in patients with nonresectable or recurrent/metastatic gastric cancer.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Combination Chemotherapy Gastric cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cetuximab Plus P-HDFL

Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.

Group Type EXPERIMENTAL

Cetuximab Plus P-HDFL

Intervention Type DRUG

Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cetuximab Plus P-HDFL

Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18 to 75 years
2. Histologically proven adenocarcinoma
3. At least one "measurable" lesion (by RECIST)
4. No prior chemotherapy for gastric cancer
5. WHO performance status ≦ 2
6. Adequate baseline organ functions
7. Fasting serum triglyceride level \> 70 mg/dL
8. Written informed consent
9. At least one month from gastrectomy
10. Availability of tumor sample for immunohistochemical or pharmacogenomic testing of EGFR

Exclusion Criteria

1. Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy
2. CNS metastasis
3. Pregnancy, breast-feeding women and women of child-bearing potential
4. Life expectancy less 3 months
5. Serious concomitant illness
6. Concurrent or prior second malignancy
7. Known hypersensitivity reaction to any of the components of study treatments
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Tri-Service General Hospital

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ann-Lii Cheng, M.D., Ph.D.

Role: STUDY_CHAIR

Department of Oncology, National Taiwan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Oncology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

941004

Identifier Type: -

Identifier Source: org_study_id