Low-dose RAD001(Everolimus) Plus Cisplatin-HDFL Chemotherapy for the First-line Treatment of Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 (everolimus) plus cisplatin and HDFL (weekly 24-hour infusion of high-dose 5-FU and leucovorin) chemotherapy in the first-line treatment for patients with unresectable, recurrent, or metastatic gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborators: National Cheng-Kung University Hospital; Taipei Veterans General Hospital, Taiwan
• Treatments: Cisplatin; Everolimus; Leucovorin; Sirolimus

Criteria

Inclusion Criteria:

1. Patients must have a histologically proven adenocarcinoma of the stomach, with unresectable locally advanced, recurrent or metastatic disease;

2. 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;

3. Patients must have at least one "measurable" lesion (by RECIST);

4. Patients must have adequate baseline organ functions, and fasting triglyceride level >/= 70 mg/mL;

5. Patients must be younger than 75 years of age;

6. Patients must have an ECOG performance status

7. Patients' life expectancy should be expected >/= 3 months;

8. Patients must sign an informed consent form.

Exclusion Criteria:

1. 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;

2. Patients who have known hypersensitivity to everolimus, sirolimus or to its derivative;

3. Patients who should not withdrawal from medication which can induce or inhibit activity of CYP3A4 during study period;

4. 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;

5. Patients with CNS metastasis;

6. Patients who refuse port-A implantation;

7. Women who are currently pregnant or breast feeding, and women of child-bearing potential without adequate contraception;

8. 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.