972 Phase I study of cyclophosphamide and docetaxel (taxotere ®) in solid tumors

Abstract

Twelve patients (pts) received cyclophosphamide (CTX) as a 1 hr infusion followed by Taxotere (TXT) as a 1 hr infusion every 21 days. Dose levels were 0: CTX/TXT 600/60 mg/m 2 (6 pts), 1: CTX/TXT 600/75 mg/m 2 (3 pts), 2: CTX/TXT 700/75 mg/m 2 (3 pts). Pts were premedicated with dexamethasone 8 mg B. I. D. at day 0–4 and oral ondansetron. Pts characteristics : tumor types: breast 4, sarcoma 4, colon 3, melanoma 1; med age, 58 yrs (31–72); med Zubrod PS, 1 (0–2); med no. sites 3 (1–5); med no. of prior CT was 1 (0–4). Response 2 PR (breast cancer), 2 SD (breast/sarcoma) Toxicity To date, 9 pts received 18 evaluable courses. Med nadir granulocytes (× 10 3 )/dl: 0.7 (med duration 7 days). Neutropenic fever was seen in 3 pts in 3 cycles. Other GRADE II tox (no. of pts, no. of cycles) : fatigue 4 (9), myalgias 1 (1), nausea 3 (3), diarrhea 2 (2), stomatitis 2 (2), skin (1) Conclusion The results of this ongoing trial showed that the combination of CTX/TXT is well tolerated and with no unexpected toxicities.