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

NCT00275951 | Completed Phase 2 DMC

• 1 other identifier: 941004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Keywords

Combination; Chemotherapy; Gastric cancer

Outcome Measures

Primary Outcomes (1)

• Confirmed objective response rates

  Confirmed objective response within 4 weeks

Secondary Outcomes (1)

• Progression-free survival (PFS), overall survival (OS), treatment-related toxicity

  3 years and 5 years

Study Arms (1)

Cetuximab Plus P-HDFL

EXPERIMENTAL

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.

Drug: Cetuximab Plus P-HDFL

Interventions

Cetuximab Plus P-HDFL 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.

Cetuximab Plus P-HDFL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy
• CNS metastasis
• Pregnancy, breast-feeding women and women of child-bearing potential
• Life expectancy less 3 months
• Serious concomitant illness
• Concurrent or prior second malignancy
• Known hypersensitivity reaction to any of the components of study treatments

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• National Health Research Institutes, Taiwan: collaborator
• Chang Gung Memorial Hospital: collaborator
• Tri-Service General Hospital: collaborator

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ann-Lii Cheng, M.D., Ph.D.

  Department of Oncology, National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 12, 2006
• Study Start: December 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

TW (1)