Primary Outcome Measures:
- Dose Limiting Toxicity (DLT) during the first two treatment cycles [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence and severity of adverse events and laboratory abnormalities, graded according to NCI-CTCAE version 3.0 [ Time Frame: During and at end of study ] [ Designated as safety issue: Yes ]
- Occurrence of Serious Adverse Events (SAEs) [ Time Frame: During and at end of study ] [ Designated as safety issue: Yes ]
- Occurrence of discontinuations due to treatment-related adverse events [ Time Frame: At end of study ] [ Designated as safety issue: Yes ]
- Serum concentrations of CBP501 and total and ultrafiltrate platinum to determine, via non-compartmental methods, Cmax, AUC, lz, t½, Cl and Vss. [ Time Frame: During and at end of study ] [ Designated as safety issue: No ]
- Evaluation of the relationship between administered dose and plasma pharmacokinetic parameters for CBP501 and cisplatin [ Time Frame: During and at end of study ] [ Designated as safety issue: No ]
- Objective tumor response assessed according to RECIST [ Time Frame: During and at end of study ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: During and at end of study ] [ Designated as safety issue: No ]
Intervention Details:
Drug: CBP501 and Cisplatin
CBP501 is given IV on Day 1 of each cycle (every 21 days). Dose escalation of CBP501 and cisplatin will be starting doses of 3.6 mg/m² CBP501 and 50 mg/m² cisplatin (Dose Level 1). Step 1, if during the first 2 cycles, at least 2 out of 3 to 6 patients experience Dose Limiting Toxicity (DLT) at 50 mg/m² cisplatin, then the cisplatin dose will be de-escalated to 30 mg/m². If no more than 1 out of 6 patients experiences DLT, cisplatin dose will be escalated to 75 mg/m². Step 2, dose escalation will be performed using the cisplatin MTD, with escalating CBP501 doses. CBP501 dose escalation will take place until the MTD has been defined or 74 mg/m² is reached.