Tumors Clinical Trial
Official title:
A Phase I Study of ASA 404 in Combination With Carboplatin/Paclitaxel/Cetuximab in Patients With Refractory Solid Tumors
This phase I trial is studying the side effects and best dose of an investigational drug called DMXAA (5-6-dimethylxanthenone-4-acetic acid) or ASA404 when given together with carboplatin, paclitaxel and cetuximab to treat patients with refractory solid tumors.
Phase I 3+3 dose escalation design in patients with solid tumors who have been previously
treated with chemotherapy or for whom no standard treatment options exist. Carboplatin,
paclitaxel and cetuximab will be administered in standard doses. The dose of ASA404 will be
escalated under predefined levels. One treatment cycle constitutes 3 weeks. A minimum of 3
patients will be entered at each treatment level, to be expanded to 6 subjects if dose
limiting toxicities (DLT) are observed. If no more than one in six patients has DLT,
additional patients will be enrolled at a higher dose. Once a maximum tolerated dose (MTD)
has been established, the tolerability of this dose will be tested in a total of 12
patients. The anticipated sample size is 18-24 patients.
Carboplatin and paclitaxel are chosen as the chemotherapy back bone since they are commonly
used in combination in multiple tumors. Cetuximab has been chosen as the EGFR inhibitor
because the combination of platinum based therapy with cetuximab is effective in lung and
head and neck cancers. In addition the safety and activity of carboplatin/paclitaxel with
ASA 404 has already been demonstrated. A weekly schedule of ASA is chosen because 1) the
safety of the weekly schedule has been tested 2) preclinical studies confirm enhanced
activity with frequent administration 3) provides an opportunity to evaluate the safety and
pharmacokinetics of ASA 404 with weekly cetuximab.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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