A/Professor Paul Vasey (NSW), A/Professor Michael Quinn (Vic), Professor John Simes (NSW), A/Professor Michael Friedlander (NSW), Dr Martin Buck (Qld) , Dr Bogda Koczwara (SA)
Royal Women's Hospital
This controlled trial is evaluating the best way to determine the dose of chemotherapy for patients with ovarian, primary peritoneal or fallopian tube cancer.
Patients for whom this trial is deemed suitable will receive 6 cycles of carboplatin chemotherapy following their diagnosis, either using conventional dosing or using a dose-escalation scheme. Patients will first undergo surgery to either biopsy or remove most of the tumour, then receive chemotherapy in one of two ways: using conventional dosing for 6 cycles (ARMA A) where dose levels remain the same for each cycle unless there is toxicity related to treatment OR using an intra-patient dose escalation scheme based on interim blood counts (ARM B).
The trial will assess whether larger doses of drug can be safely delivered to a proportion of patients, improving the effectiveness of treatment without significantly increasing side effects. The trial will assess the effects of these dosing strategies primarily on the time to disease progression, as well as on survival, tumour response and patient assessed Quality of Life.
If the results of this study demonstrate an advantage for intrapatient dose escalation of carboplatin in frontline treatment, this will change the way this drug is used in clinical practice and further impact on how best to use carboplatin in other trials. It may also help in deciding how best to use carboplatin in combination with other ovarian cancer drugs such as the taxanes.
$30,000 in 2006, $36,000 in 2007, $38,000 in 2008