om 135 to 300 mg/m2 administered over 24 hours (in four of these studies, G-CSF was administered as hematopoietic support). Three hundred and one patients were treated in the randomized Phase 3 ovarian carcinoma study which compared two doses (135 or 175 mg/m2) and two schedules (3 or 24 hours) of paclitaxel. Two hundred and thirty-six patients with breast carcinoma received paclitaxel (135 or 175 mg/m2) administered over 3 hours in a controlled study.
Table 4: Summarya of Adverse Events in Patients With Solid Tumors Receiving Single-Agent Paclitaxel
Percent of Patients
• Bone Marrow
(n=812)
- Neutropenia < 2,000/mm3
90
< 500/mm3
52
- Leukopenia < 4,000/mm3
90
< 1,000/mm3
17
- Thrombocytopenia < 100,000/mm3
20
< 50,000/mm3
7
- Anemia < 11 g/dL
78
< 8 g/dL
16
- Infections
30
- Bleeding
14
- Red Cell Transfusions
25
- Platelet Transfusions
2
• Hypersensitivity Reactionb
- All
41
- Severe†
2
• Cardiovascular
- Vital Sign Changesc
