| Eligibility |
Inclusion criteria
- Male or female patients = 18 years of age
- Ability and willingness to give written informed consent
- Patients scheduled to receive, on day 1 of their chemotherapy, either: (i) a first
cisplatin chemotherapy infusion at a dose of =70 mg/m2 (males and females); or (ii) a
first infusion of cyclophosphamide at a dose of 500-1500 mg/m2 in combination with
either epirubicin at a dose of 60-100 mg/m2 or doxorubicin at a dose of 40-60 mg/m2
(females only)
- Karnofsky performance score = 60%
- Adequate cardiac, hepatic and renal function
- QTc interval < 500 ms
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 5 x
upper limit normal (ULN)
- Bilirubin < 5 x ULN
- Creatinine < 3 x ULN
- Adequate haematological function
- Haemoglobin = 8 g/dL
- White blood count = 3.0 x 109/L
- Platelet count = 100 x 109/L
- For females of child-bearing potential: ability and willingness to use a highly
effective form of contraception (e.g., abstinence from sexual intercourse, surgical
sterilisation (of subject or partner) or a double-barrier method of contraception such
as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in
conjunction with partner's use of a condom) during the study and for a period of at
least 48 hours afterwards
Exclusion Criteria
- Patients scheduled to receive, prior to or in the 120 hours after cisplatin or AC, any
other chemotherapeutic agent with a high or moderate emetic risk
- Patients who have previously received anti-neoplastic chemotherapy
- Patients scheduled to receive paclitaxel or docetaxel during the first cycle of their
chemotherapy
- Patients undergoing abdominal or pelvic irradiation within 48 hours prior to screening
or scheduled to receive abdominal or pelvic irradiation between screening and 24 hours
after cisplatin or AC administration
- Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or
confirmed prolactin-dependent breast cancer) or phaeochromocytoma
- Patients with a pre-existing vestibular disorder
- Patients being treated with regular anti-emetic therapy including corticosteroids
- Patients receiving inhaled corticosteroids, unless started more than one month prior
to the expected date of study entry
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