A Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Metastatic Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099527
• Other study ID #: 2009-02-041
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 6, 2010
• Last updated: December 28, 2015
• Start date: October 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Everolimus (RAD001)
dose escalation of capecitabine, everolimus
• Capecitabine
dose escalation of capecitabine, everolimus

Locations

Country	Name	City	State
Korea, Republic of	Samsung Cancer Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine maximum tolerated dose (MTD) in phase I		1 year	Yes
Primary	To assess response rate in phase II		1 year	Yes