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Annals of Oncology 11:1603-1608, 2000
© 2000 European Society for Medical Oncology

research-article

Phase II clinical trials of cisplatin-then-paclitaxel and paclitaxel-then-cisplatin in patients with previously untreated advanced epithelial ovarian cancer

C. J. Poole1,3,4,, T. Perren2, A. Burton1, S. D. Jordan1,4, A. H. Jenkins2, J. J. Mould3, D. A. Spooner3, D. Luesley4,5, K. K. Chan5, S. Sturman4 and H. M. Earl6

1CRC Trials Unit, Institute for Cancer Studies, University of Birmingham Birmingham
2ICRF Cancer Medicine Research Unit, St James's University Hospital Leeds
3Queen Elizabeth Hospital Birmingham
4City Hospital NHS Trust Birmingham
5Birmingham Women's Hospital Birmingham
6Department of Oncology, University of Cambridge Cambridge, UK

Correspondence to: Dr C. J. Poole CRC Trials Unit Institute for Cancer Studies University of Birmingham Edgbaston, Birmingham, B15 2TT UK E-mail: PooleCJ{at}aol.com

Purpose: To examine the activity and safety of two sequentially scheduled chemotherapy regimens comprising four cycles of paclitaxel (pctx) 200 mg/m2/3 hours then four cycles of cisplatin (cisDDP) 100 mg/m2, and vice versa, in patients with previously untreated advanced ovarian cancer.

Patients and methods: Between January 1994 and February 1996, we recruited 30 patients to the pctx-then-cisDDP regimen and 29 to cisDDP-then-pctx, in parallel phase II trials.

Results: Both regimens were predictably active with responses seen in 22 of 30 patients (OR 74% CR 27%, PR 47%) treated with pctx-then-cisDDP, as against 13 of 21 patients (OR 62% CR 38% PR 24%) treated with cisDDP-then-pctx, The OR rate to four cycles of pctx (induction) was 43%, with 27% disease progression; the OR to four cycles of cisDDP (induction) was 57%, with 5% progression. However, progression rates across both induction and consolidation phases were 16% (pctx-then-cisDDP) and 29% (cisDDP-then-pctx). Both regimens were unacceptably neurotoxic, 11 patients suffering grade 3 sensory neurotoxicity (5 on pctx-then-cisDDP, 6 on cisDDP-then-pctx) and 20 having grade 3 deafness (9 on pctx-then-cisDDP, 11 on cisDDP-then-pctx).

Conclusion: The activity of these sequential regimens justifies their further development using the less neurotoxic platinum analogue carboplatin, perhaps combining paclitaxel with other platinum non-cross resistant drugs.

cisplatin, ovarian cancer, paclitaxel, sequential chemotherapy


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