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A population-based clinical trial of irinotecan and carboplatin
Journal of Oncology, 06/15/09

Lau D et al. – Study demonstrates that the population-based design of phase I trial allows optimization of dose intensity and derivation of a population-based maximum tolerated dose (pMTD). The pMTD has been applied in phase II trial of irinotecan and carboplatin in patients with small-cell lung cancer.

Methods

Study describes a population-based design for phase I trials of combining anticancer drugs such as irinotecan and carboplatin
Intrapatient dose escalation of irinotecan and carboplatin was performed to reach individual dose-limiting toxicity (DLT)
50 pts with solid tumors refractory to previous chemotherapy
The individual toxicity-limiting dose levels were analyzed for normal distribution using the method of Ryan-Joiner
This was subsequently used to determine a pMTD
For comparison, a simulation study was performed using the method of modified Fibonacci

Results

Most common DLTs: neutropenia (58%), thrombocytopenia (16%), and diarrhea (8%)
Fequency of individual toxicity-limiting dose levels of 50 pts approximated a normal distribution
Dose levels associated with individual limiting toxicities ranged from level 1 to level 8
pMTD was determined to be dose level 3 (150mg/m2 for irinotecan and AUC=5 for carboplatin)
In contrast, the MTD was determined to be dose level 4 (200mg/m2 for irinotecan and AUC 5 for carboplatin) by modified-Fibonacci simulation

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A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic NSCLC
Annals of Oncology, 10/19/09 Relevance Score: 90%

Persistent nephrotoxicity during 10-year follow-up after cisplatin or carboplatin treatment in childhood: Relevance of age and dose as risk factors
European Journal of Cancer, 10/23/09 Relevance Score: 89%

DNA damage induced by cis- and carboplatin as indicator for in vitro sensitivity of ovarian carcinoma cells
BMC Cancer, 10/15/09 Relevance Score: 89%

Phase I dose-finding study of paclitaxel with panitumumab, carboplatin and intensity-modulated radiotherapy in patients with locally advanced squamous cell cancer of the head and neck
Annals of Oncology, 11/10/09 Relevance Score: 88%

Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer unfit for cisplatin-based chemotherapy: Phase II--results of EORTC Study 30986
Journal of Clinical Oncology, 10/05/09 Relevance Score: 87%