A Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Study Overview
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Brief Summary
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Capecitabine is an oral fluoropyrimidine that has been shown to be effective in the treatment of metastatic gastric and colorectal cancer patients. On the basis of capecitabine-based chemotherapy which is accepted as a standard regimen in gastric cancer, we will perform the phase I/II study with all-oral regimen of RAD001 with capecitabine for these refractory gastric cancer patients.

Official Title
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A Phase I/II Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Conditions
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Metastatic Gastric Cancer

Intervention / Treatment
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* Drug: Everolimus (RAD001)
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically proven gastric cancer patients Adequate organ function as defined by the following criteria: A. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B. Total serum bilirubin ≤ 3.0 mg/dL C. Absolute neutrophil count (ANC) ≥1500/µL D. Platelets ≥100,000/µL E. Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F. Serum calcium ≤12.0 mg/dL G. Serum creatinine ≤1.5 x ULN Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks Patients who have failed to at least two previous cytotoxic chemotherapy for advanced gastric cancer (adjuvant treatment will be counted as one regimen if received < 12 months from the start of experimental treatment) At least one measurable lesion by RECIST criteria ECOG PS 0-2 Patients with informed consent Exclusion Criteria: Major surgery or radiation therapy within 4 weeks of starting the study treatment. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2. Pregnancy or breastfeeding. Prior exposure to the study drug. Patients unable to swallow oral medications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Everolimus<br>Everolimus (RAD001) dose escalation of capecitabine, everolimus Capecitabine dose escalation of capecitabine, everolimus | Drug: Everolimus (RAD001)<br>* dose escalation of capecitabine, everolimus<br>Drug: Capecitabine<br>* dose escalation of capecitabine, everolimus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine maximum tolerated dose (MTD) in phase I |  | 1 year | 
| To assess response rate in phase II |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, refractory, metastatic