Clinical trial NCT01099527: A Trial of RAD001/Capecitabine in Refractory Gastric Cancer
Official title: A Phase I/II Trial of RAD001/Capecitabine in Refractory Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Gastric Cancer
Keywords: gastric cancer
refractory
metastatic
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-04-07
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To determine maximum tolerated dose (MTD) in phase I
timeFrame: 1 year
measure: To assess response rate in phase II
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Cancer Center
Study officials:
References:
citation: Lee SJ, Lee J, Lee J, Park SH, Park JO, Park YS, Lim HY, Kim KM, Do IG, Jung SH, Yim DS, Kang WK. Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients. Invest New Drugs. 2013 Dec;31(6):1580-6. doi: 10.1007/s10637-013-0022-0. Epub 2013 Sep 7.