Cancer Clinical Trial
Official title:
A Phase I Study of TS-1, Cisplatin & RAD001 (Everolimus)
Hypothesis: The addition of RAD001 to TS-1/CDDP is safe and can improved the efficacy of
TS-1/CDDP. The rationale for combining RAD001 with TS-1/CDDP are:
1. Potential synergism for the combination TS-1/CDDP Activation of the PI3K/AKT/mTOR
pathway is frequently a characteristic of worsening prognoses (through increased
aggressiveness), resistance to treatment, extension of disease and progression. The
antitumour effect of RAD001 is mediated through the antiproliferative and
antiangiogenic activity of mTOR inhibition. In preclinical study, RAD001 demonstrated
synergism with CDDP in several cancer types including lung (A549; CI 0.47), epidermoid
cancer (KB-31; CI 0.74), colon cancer (HCT116; CI 0.47) and gastric cancer (SNU 1; CI
0.204, SNU 216; CI 0.546, SNU 638; CI 0.039, SNU 668; CI 0.396) (IB, Lee 2008 AACR).
2. Potential for overcoming TS-1/CDDP resistance. Upregulation of Akt pathway was found to
be an important mechanism for acquired resistance to CDDP (Lee 2005 Gyn Onc, Liu 2007
Cancer Res). In addition, gastric cancers with upregulated Akt pathway are associate
with primary resistance to 5- fluorouracil, adriamycin, mitomycin C, and cisplatin (Oki
2007 PASCO)
3. Overlapping antitumour activities with TS-1/CDDP RAD001 is effective and well tolerated
against subcutaneous tumours established from a variety of tumour cell lines of diverse
histotypes (NSCLC, pancreatic, gastric, colon, renal, melanoma, epidermoid), including
a Pgp170-overexpressing, multi-drug resistant tumor line. Partial response to single
agent RAD001 was seen in a patient with gastric cancer at the dose of 5mg/day and 2
patients (gastric and oesophageal cancer) at the dose of 10mg/day, in study C2101 and
C1101 respectively. A clinical benefit (stable disease, partial response and complete
response) was observed in 55% of patient with gastric cancer who had failed 1st line
therapy (Yamada 2009 GCS ASCO). A phase III study of RAD001 in patients with 2nd/3rd
line gastric cancer has currently opened for recruitment.
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