Metastatic Colorectal Cancer Clinical Trial
Raltitrexed is a potent thymidylate synthase (TS) inhibitor. Conversely to 5-fluorouracil
(5FU), raltitrexed can be administered safely in patients with cardiovascular disease, as
well as in patients with dihydropyrimidine dehydrogenase deficit. Since raltitrexed is
administered in 15-minutes infusion, complications related to continuous infusion can be
avoided, and it becomes a potential good candidate for locoregional treatments as hepatic
intra-arterial or intra-peritoneal infusion. Despite these potential benefits over 5FU,
clinical trials failed in their temptation to replace the 5FU in colorectal cancer patients,
mainly due to raltitrexed toxicity at 3mg/m2 every 3 weeks. Oxaliplatin has demonstrated a
synergic effect when combined with TS inhibitors, and its association with raltitrexed was
evaluated at 130mg/m2 of oxaliplatin and 3mg/m2 of raltitrexed, every 3 weeks. Actually, one
of the first-line standard regimens in metastatic colorectal cancer patients is the biweekly
FOLFOX (85mg/m2 of oxaliplatin, and infusional 5FU) plus bevacizumab regimen, since a
significant progression-free survival (PFS) benefit was observed over FOLFOX plus placebo.
Biweekly administration of raltitrexed at 2mg/m2 demonstrated a favorable toxicity profile
even in patients aged >65 years. Besides, the association of raltitrexed, oxaliplatin and
bevacizumab seems safe.
Then, the investigators decided to perform a randomized pharmacokinetic comparative study
between biweekly TOMOX (raltitrexed 2 mg/m2 and oxaliplatin 85mg/m2) and triweekly TOMOX
(raltitrexed 3 mg/m2 and oxaliplatin 130mg/m2) regimens in metastatic colorectal cancer
patients, in a "ping-pong" crossover strategy to reduce the intra-individual variability.
Bevacizumab was allowed at the dose of 5mg/kg or 7.5mg/kg, in biweekly and triweekly
schedules, respectively. The secondary end-points were, objective response rate evaluated by
RECIST 1.1 criteria, PFS, overall survival (OS), toxicity, and the comparison of toxicity
between two arms for the first 2 cycles.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 |