Table 1

Clinical trials addressing paclitaxel dosing

Clinical trialDesignSignificant results
Ovary cancer
 BMS 016 (Ov.9)NCIC CTG studyPFSa longer in high-dose arm (19 vs. 14 weeks).
Recurrent or refractory ovarian cancerNo differences in response rates or overall survival
Bifactoral randomization
 3 vs. 24 h
 135 vs. 175 mg/m2
 GOG 134Gynecologic Oncology Group studyResponse rate higher in high-dose arm (36% vs. 28%)
Recurrent or refractory ovarian cancerNo difference in PFS or overall survival
Randomization
 Initial: 135 vs. 175 vs. 250 mg/m2 + G-CSF (24-h  schedule)
 Final: 175 vs. 250 mg/m2 + G-CSF
Breast cancer
 BMS 048Metastatic Breast Cancer (adjuvant therapy only, therapy for metastatic cancer only, and therapy in  both adjuvant and metastatic settings).PFS longer in high-dose arm (4.2 vs. 3 months)
RandomizationNo difference in response rates or overall survival
 135 vs. 175 mg/m2 over 3 h
 CALGB 9342Metastatic breast cancerIncidences or severe myelosuppression and neurotoxicity in moderate- and high-dose arms
Second line treatmentBorderline correlation between dose and time to treatment failure (3.8, 4.1, and 4.8 months)
RandomizationNo difference in response rates or survival
 175 vs. 210 vs. 250 mg/m2 over 3 h
Lung cancer
 ECOG 5592Metastatic non-small cell lung carcinomaHigher response rates in both low- and high-dose paclitaxel arms (26.5 and 32.1%) than etoposide arm (12%).
RandomizationLonger PFS in both low- and high-dose paclitaxel arms (9.59 and 9.99 months) than etoposide arm (7.69 months)
 Cisplatin/etoposide vs. cisplatin/low-dose paclitaxel,  135 mg/m2 (24-h schedule) vs. cisplatin/high-dose  paclitaxel, 250 mg/m2 (24-h schedule) + G-CSFNo differences between paclitaxel arms
Paclitaxel CSS values different between high-dose and low-dose arms, but no relationships between CSS and response, time to progression, and survival
Head and neck cancer
 ECOG 1393Advanced head and neck carcinoma35% response rate in both arms
RandomizationNo differences between high- and low-dose paclitaxel arms
Cisplatin/low-dose paclitaxel, 135 mg/m2 (24-h schedule) vs. cisplatin/high-dose paclitaxel, 200 mg/m2 (24-h schedule) + G-CSF
  • a PFS, progression-free survival.