Recurrent ovarian cancer
Conditions
Interventions
Product Code: ZK 00219477
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females aged =18 years 2. Histologically proven cancer of any of the following types: - Epithelial ovarian cancer - Peritoneal cavity cancer - Fallopian tube cancer 3. Suitability of response assessment by the following: - Measurable disease according to modRECIST, or - CA-125 levels = 2 times upper limit of normal (ULN) within 2 weeks prior to the first infusion 4. WHO performance status 0-1 5. Up to 2 previous chemotherapies; the most recent chemotherapy must have been a platinum-containing therapy 6. Progression of measurable disease or symptomatic relapse during or within 6 months of previous therapy (elevated CA-125 levels alone are insufficient for inclusion) 7. Time period since prior therapy: - Prior radiotherapy: = 4 weeks - Prior chemotherapy: = 4 weeks - Prior immunotherapy: = 3 weeks 8. Adequate recovery from previous surgery, radiation, and chemotherapy (excluding alopecia) 9. Adequate function of major organs and systems - Nervous system: - No peripheral neuropathy = Grade 2 - No altered mental status - Hematopoietic: - Hemoglobin = 9 g/dL - Absolute neutrophil count = 1,500/mm3 - Platelet count = 100,000/mm3 - Hepatic: - Bilrubin within normal range - AST/ALT = 5 x ULN - Renal: - Creatinine = 1.5 x ULN - Cardiovascular: - No symtomatic congestive heart failure - No unstable angina pectoris - No arrhythmia needing continuous treatment - No other uncontrolled concurrent illness 10. Survival expectation = 3 months 11. written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than 2 previous chemotherapies 2. Prior treatment with epothilones 3. Use of any investigational drug within 4 weeks before start of study treatment or inadequate recovery from any toxic effects of such therapy 4. Previous radiation to the whole pelvis 5. Symptomatic brain metastases requiring whole-brain irradiation 6. Active infection 7. Any concomitant malignancy; the following exceptions are allowed; - Non-melanoma skin cancer - Carcinoma in situ of the cervix - Malignancy with definitive treatment = 5 years ago without relapse 8. Mixed mesodermal tumor (MMT) 9. Prior hormone therapy for any malignancy within 1 month 10. Childbearing potential 11. Any conditions that in the opinion of the investigator could affect the compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of ZK 219477 in patients with recurrent ovarian cancer progressing during, or within 6 months of platinum-based chemotherapy (proof of concept); Secondary Objective: To investigate the safety and tolerability of ZK 219477 in this patient population To assess the impact of the infusion duration on the tolerability of ZK 219477 ; Primary end point(s): In patients with measurable disease: - Proportion of patients with either CR or PR as best overall response In patients without measurable disease: - Proportion of patients with = 50% reduction in CA-125 levels compared to the pretreatment sample | — |
Countries
United Kingdom
Outcome results
None listed