Eng, C., Mauer, A.M., Fleming, G.F., Bertucci, D., Rotmensch, J., Jacobs, R.H., & Ratain, M.J. (2001). Phase I study of pegylated liposomal doxorubicin, paclitaxel, and cisplatin in patients with advanced solid tumors. Annals of Oncology, 12, 1743–1747.

To evaluate the effectiveness of pyridoxine to prevent palmar plantar erythrodysesthis (PPE) in patients receiving pegylated liposomal doxorubicin (PLD) (Doxil^®) in patients with advanced solid tumors

Patients were receiving a treatment regimen consisting of PLD (doses escalating in dose level 1–4 from 20–40 mg/m²every 21 days), in combination with paclitaxel (90 mg/m² in dose level 1, 135 mg/m² in dose levels 2–4), and cisplatin (60 mg/m²). All patients were given oral pyridoxine 50 mg three times daily on days 2–21 of each cycle. The study occurred from May 1997–March 2000.

• N = 23
• KEY DISEASE CHARACTERISTICS: Patients with advanced solid tumors
• OTHER KEY SAMPLE CHARACTERISTICS: Receiving PLD, paclitaxel, and cisplatin

• LOCATION: Department of Medicine, University of Chicago, Chicago, IL

• Phase I study

• National Cancer Institute Common Toxicity Criteria version 1.0

No episodes of grade 3–4 (dose-limiting) PPE were reported. Grade 1–2 PPE occurred in 4 of 18 patients (22%) who received more than two cycles of chemotherapy, resulting in no treatment-related interruptions or dose reductions.

Incidence of PPE was low in patients who received pyridoxine prophylactically and Doxil 20–40 mg/m².

• Small sample size
• This was not a randomized controlled trial.