Gemcitabine in Combination With Pemetrexed Long Term Infusion in the Treatment of Pretreated Metastatic Colorectal Cancer Patients

• Status: Completed
• Trial end date: 2014-03-01

Summary

Study Design:

Multicenter, non randomized, open label phase II study designed to evaluate the efficacy and safety of Gemcitabine/Pemetrexed combination.

Enrollment period: 18 months. Treatment period: maximum for 24 weeks for each patient (12 cycles lasting 2 weeks).

Total duration of the study: 24 months.

Number of Subjects:

Approximately 38 subjects will be enrolled on study:

• First stage:12 patients enrolled

If 1 or 0 responses were observed, the trial had to be terminated:

• Second stage: an additional of 23 patients were to be enrolled. If 5 or less responses were observed in 35 patients, the combination would not be considered worthy of further study, while if 6 or more responses were observed, the combination would be considered sufficiently active to warrant further testing. Taking into account an invalidity rate of 5%, 38 patients will be needed for this step.

• Phase: Phase 2

Details

• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Treatments: Gemcitabine; Pemetrexed