A Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Phase 1

Completed

• Conditions: Metastatic Gastric Cancer
• Interventions: Drug: Everolimus (RAD001); Drug: Capecitabine

• Registration Number: NCT01099527
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-06
• Study First Posted: 2010-04-07
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. Histologically or cytologically proven gastric cancer patients

2. 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

3. Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks

4. 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)

5. At least one measurable lesion by RECIST criteria

6. ECOG PS 0-2

7. Patients with informed consent

Exclusion Criteria

1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.
2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
4. Pregnancy or breastfeeding.
5. Prior exposure to the study drug.
6. Patients unable to swallow oral medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus	Everolimus (RAD001)	Everolimus (RAD001) dose escalation of capecitabine, everolimus Capecitabine dose escalation of capecitabine, everolimus
Everolimus	Capecitabine	Everolimus (RAD001) dose escalation of capecitabine, everolimus Capecitabine dose escalation of capecitabine, everolimus

Primary Outcome Measures

Name	Time	Method
To determine maximum tolerated dose (MTD) in phase I	1 year
To assess response rate in phase II	1 year

Trial Locations

Locations (1)

Samsung Cancer Center; 🇰🇷 Seoul, Korea, Republic of