Oncology Medical News about capecitabine, mitomycin C, gastrointestinal malignancies

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A phase I dose escalation study of a pharmacobiologically based scheduling of capecitabine and mitomycin C in patients with gastrointestinal malignancies
Cancer Chemotherapy and Pharmacology, 08/12/09

Bekaii-Saab T et al. - In a phase I dose escalation study of capecitabine and mitomycin C (MMC) in pts with gastrointestinal malignancies, it was concluded that capecitabine in combination with MMC is well-tolerated with evidence of preliminary activity. The recommended dose for phase II studies are MMC at 6 mg/m2 on day 1 of a 28-day cycle with dose capped at 36 mg/m2, in combination with capecitabine at 1000 mg/m2 twice daily on days 8–21.

Methods

29 pts with advanced gastrointestinal malignancies received MMC at 6 mg/m2 on day 1 and capecitabine escalated in 4 successive pt cohorts of doses 500–1000 mg/m2/day twice daily on days 8–21, every 28 days.
MMC was capped at 36 mg/m2.

Results

29 pts were enrolled and 90% had at least 1 prior treatment in the metastatic setting.
There was 1 DLT, grade 3 hand and foot syndrome, at dose level 4.
Most common toxicity was fatigue (61%).
No pts experienced grade 4 toxicities; 9 pts experienced prolonged stability of disease.

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