Status:
UNKNOWN
Study of Cetuximab Plus P-HDFL for the First-Line Treatment of Advanced Gastric Cancer
Lead Sponsor:
Far Eastern Memorial Hospital
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Detailed Description
Non-resectable gastric cancer is an incurable disease. Systemic chemotherapy confers prolongation of survival and improvement of quality of life. Regimens containing cisplatin and 5-fluorouracil (5-FU...
Eligibility Criteria
Inclusion
- Age 18 to 75 years
- Histologically proven adenocarcinoma of the stomach that is nonresectable, locally advanced, or recurrent/metastatic
- At least one measurable lesion (by RECIST, Response Evaluation Criteria in Solid Tumors), and no prior radiotherapy to the target measurable lesion
- No prior chemotherapy for gastric cancer, but post-gastrectomy adjuvant therapy with low-dose 5-FU \[e.g., 5-FU 450 mg/m2 per week\] completed more than 6 months before study enrollment is acceptable
- World Health Organization (WHO) performance status 2
- Adequate baseline organ functions (checked within one week before entry into this study), defined as WBC count 3,000 cells/µL with neutrophils ≥ 1,500 cells/µL, platelet count 100,000 cells/µL, hemoglobin 9 g/dL, serum total bilirubin level 1.5 X UNLs (upper normal limits), serum AST and ALT 2.5 X ULNs (or serum AST and ALT 5.0 X ULNs for patients with liver metastases), serum creatinine level 1.5 X UNLs, 24-hour urine CCr 60 ml/min
- Fasting serum triglyceride level \> 70 mg/dL, which should be checked within one week before entry into this study. The lower limit for fasting serum triglyceride (70 mg/dL) is set to avoid HDFL-related hyperammonemic encephalopathy, which occurs in around 5% of Taiwanese patients.
- Written informed consent
- At least one month from gastrectomy, in case gastrectomy was performed; at least 2 weeks from laparotomy without resection, in case laparotomy was performed to document nonresectable status
- Availability of tumor sample for retrospective testing of EGFR (pharmacogenomic mutation analysis and immunohistochemical staining).
Exclusion
- Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy other than indicated in this protocol
- CNS metastasis
- Pregnant women, breast-feeding women, and women of child-bearing potential or fertile men without adequate contraception
- Life expectancy less than 3 months
- Serious concomitant illness or significant dysfunction of major organ systems which prohibit chemotherapy, such as:
- symptomatic heart disease, including significant arrhythmias, congestive heart failure or myocardial infarction within 12 months.
- extensive liver disease.
- major active infection.
- severe symptomatic pulmonary disease.
- Concurrent or prior second malignancy (except curatively resected cervical carcinoma in situ or squamous cell carcinoma of skin).
- Known hypersensitivity reaction to any of the components of study treatments.
- Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
- Significant diseases, in the investigator's opinion, which would exclude the patient from the study.
- Legal incapacity or limited legal capacity.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00384878
Start Date
June 1 2006
Last Update
February 9 2009
Active Locations (1)
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1
Kun Huei Yeh, Ph.D
Taipei, Ban-Ciao, Taiwan, 220