Non-Small Cell Lung Cancer Clinical Trial
Official title:
Phase 1 Study of Oral Vinorelbine in Combination With Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Using Two Different Schedules
The purpose of this study is to define the schedule and dose of oral vinorelbine (Navelbine) to be used with erlotinib in non-small cell lung cancer.
Additive or supraadditive activity of an EGFR TK-I with vinorelbine has been demonstrated
in-vitro. Clinical synergism has also been described between gefitinib and vinorelbine in
NSCLC. The use of cytotoxics in a metronomic schedule has not been well investigated in the
clinical setting despite emerging pre-clinical data. Using an established oral cytotoxic
such as oral vinorelbine in a metronomic dose-schedule is attractive due to the oral route
of administration. Preclinical studies have shown that by using cytotoxics in a low-dose
protracted manner, endothelial cells are preferentially affected via inhibition of
proliferation and induction of apoptosis. In addition to this anti-angiogenic mechanism, an
anti-vasculogenic process may also be involved that acts by reducing circulating endothelial
progenitor mobilization and viability. Moreover, it has also been shown that tumours that
were selected for high levels of acquired resistance to cytotoxics can be induced to respond
by using metronomic doses of chemotherapy.
Continuous administration of metronomic oral vinorelbine, given three times a week, has been
reported as feasible and well tolerated at doses up to 180 mg total dose per week. Early
results showed activity against refractory solid tumors such as renal cancer, NSCLC, ovarian
cancer, prostate cancer, unknown primary and Kaposi sarcoma.
This phase I study combines erlotinib and oral vinorelbine on two different schedules. The
conventional schedule vinorelbine (CSV) aims to determine the MTD of conventional schedule
of oral vinorelbine given on days 1 and 8 every 21 days plus daily erlotinib and the
metronomic schedule vinorelbine (MSV) aims to determine the optimal metronomic dose of
vinorelbine given 3 times a week plus daily erlotinib.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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