Status:
COMPLETED
Low-dose RAD001(Everolimus) Plus Cisplatin-HDFL Chemotherapy for the First-line Treatment of Advanced Gastric Cancer
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Cheng-Kung University Hospital
Taipei Veterans General Hospital, Taiwan
Conditions:
Metastatic Gastric Cancer
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
The primary end-point of this study is to evaluate the objective response rates, and the secondary end-points are overall survival, progression-free survival and safety profile of low-dose RAD001 (eve...
Detailed Description
Non-resectable gastric cancer is an incurable disease, with a median survival of 4 months if untreated. Systemic chemotherapy confers prolongation of survival and improvement of quality of life. Regim...
Eligibility Criteria
Inclusion
- Patients must have a histologically proven adenocarcinoma of the stomach, with unresectable locally advanced, recurrent or metastatic disease;
- Patients must receive no prior chemotherapy for unresectable locally advanced, recurrent or metastatic gastric cancer. Previous post-gastrectomy adjuvant therapy should be completed more than 6 months before enrollment;
- Patients must have at least one "measurable" lesion (by RECIST);
- Patients must have adequate baseline organ functions, and fasting triglyceride level \>/= 70 mg/mL;
- Patients must be younger than 75 years of age;
- Patients must have an ECOG performance status \</= 2;
- Patients' life expectancy should be expected \>/= 3 months;
- Patients must sign an informed consent form.
Exclusion
- Patients who have received radiotherapy, chemotherapy, or other experimental therapy within the previous 4 weeks or who are planning to receive such therapies simultaneously with RAD001 plus P-HDFL;
- Patients who have known hypersensitivity to everolimus, sirolimus or to its derivative;
- Patients who should not withdrawal from medication which can induce or inhibit activity of CYP3A4 during study period;
- Patients who have uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations;
- Patients with CNS metastasis;
- Patients who refuse port-A implantation;
- Women who are currently pregnant or breast feeding, and women of child-bearing potential without adequate contraception;
- Patients who have another prior malignancy, except for adequately treated basal cell, cervical carcinoma in situ, or any cancer from which the patient has been disease-free for 5 years.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00632268
Start Date
February 1 2008
End Date
December 1 2012
Last Update
August 21 2013
Active Locations (1)
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1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 10002