Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma
- Define an individually adapted (by dosage) protocol of pemetrexed disodium, cisplatin,
and vitamin B12 in patients with unresectable pleural mesothelioma.
- Determine the relationship between pharmacokinetic and pharmacodynamic parameters
(hematologic and nonhematologic).
- Analyze the inter-individual pharmacokinetic variations and the influence of the
covariables on the pharmacokinetics of pemetrexed disodium.
- Analyze the impact of pharmacogenetic (MTHFR, TS, GSTpi, ERCC1, XPD) variations on the
toxicity of pemetrexed disodium.
- Validate a strategy of adapting dosage.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day
1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression
or unacceptable toxicity. Patients also receive vitamin B12 intramuscularly on day -7 and
then every 9 weeks until chemotherapy is completed.
Blood samples are collected during the first and third courses of chemotherapy. Samples are
analyzed by pharmacogenetic (MTHFR, TS, GSTpi, ERCC1, xPD), pharmacokinetic, and other
Allocation: Non-Randomized, Primary Purpose: Treatment
Individual dosage-adapted protocol
Amelie Lansiaux, MD, PhD
Centre Oscar Lambret
United States: Federal Government