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

NCT00632268 | Completed Phase 2 DMC

• 1 other identifier: 200612015M
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Metastatic Gastric Cancer

Keywords

mTOR inhibitor; RAD001; everolimus; chemotherapy; cisplatin; high-dose 5-FU

Outcome Measures

Primary Outcomes (1)

• To evaluate the confirmed objective response rates (complete and partial responses)

  2008 ~2009

Secondary Outcomes (1)

• To assess the overall survival(OS), progression-free survival(PFS), treatment-related toxicities, and pharmacokinetic profile of RAD001 used in combination with 5-FU and cisplatin

  2009~2010

Study Arms (1)

A

EXPERIMENTAL

Drug:RAD001 Drug:Cisplatin Drug:5-FU

Drug: RAD001; Cisplatin; 5-FU; Leucovorin

Interventions

RAD001; Cisplatin; 5-FU; Leucovorin DRUG

RAD001: oral 10mg/day on Day 1,8,15 Cisplatin:infusion 35mg/m2/day on Day 1,8 5-FU:infusion 2000mg/m2/day on Day 1,8,15

A

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Cheng-Kung University Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Everolimus; Cisplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Kun-Huei Yeh, M.D.,Ph.D.

  Department of Oncology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 10, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

TW (1)