None listed
Conditions
Interventions
4 cycles of docetaxel where a cycle is once a week for 5 weeks followed by a rest week.
Sponsors
NHMRC Clinical Trial Centre c/- Univ of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven epithelial carcinoma of the ovary, primary peritoneal carcinoma or fallopian tube carcinoma. * Patients must have previously received paclitaxel, and relapsed or progressed after cessation of paclitaxel. * Patients must have been treated previously with at least one platinum-containing chemotherapy regimen (platinum refers to either carboplatin or cisplatin). * Patients must have disease that is unidimensionally measurable or be suitable for assessment of CA125 response. Patients without measurable disease who are to be followed by CA125 must have a CA125 > 70 U/ml. * Patients may or may not have received hormonal therapy, immunotherapy or localized radiation therapy (previous radiotherapy exposure should not compromise the evaluation of the measurable/evaluable disease sites). Patients must have been off all previous non-cytotoxic therapy for at least four weeks before study entry and must have recovered from the effects of prior therapy. For patients on hormonal therapy who have clear evidence of progression on this treatment, a 2-week interval will be acceptable. Prior radiotherapy should have involved < 25% of bone marrow. * No prior chemotherapy/investigational drug therapy in the 4 weeks preceding study entry. In case of previous treatment with mitomycin-C, high-dose carboplatin (dose > 600mg/m2 or > AUC 7) or nitrosoureas, a 6-week interval will be required. * WHO performance status 0-2. * Non-pregnant, non-lactating female patients. Patients of childbearing potential must implement adequate contraceptive measures during study participation. * Age > 18 years. * Life expectancy greater than or equal to 12 weeks. * Adequate haematological, renal and hepatic functions as defined by: (i) Haematology: - Neutrophils > 1.5 x 109/l- Platelets > 100 x 109/l. (ii) Hepatic function:- Total bilirubin < upper-normal limit (UNL). - AST and ALT < 2.5 x UNL. - ALP < 5 x UNL (unless patient has bone metastases without any malignant or non-malignant liver disease). - Patients with AST and /or ALT > 1.5 x UNL associated with ALP > 2.5 x UNL are not eligible for the study. (iii) Renal function: - Creatinine < 1.5 x UNL. * Patient's written informed consent must be obtained before any study specific screening procedures are performed, and in accordance to the local Ethics Committee requirements. * Patients must be accessible for treatment and follow-up.
Exclusion criteria
No exclusion criteria
Outcome results
None listed