Randomized, multicentre, prospective, two-arm, open-label Phase II study to investigate the efficacy and safety of two ZK219477 i.v. infusions (3-hour infusion of 16mg/m2 versus 0.5-hour infusion of 16mg/m2) in patients with recurrent ovarian cancer progressing during, or within 6 months of the end of platinum-based chemotherapy
- Conditions
- Recurrent ovarian cancer
- Registration Number
- EUCTR2005-000635-15-GB
- Lead Sponsor
- Schering AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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);<br> Secondary Objective: To investigate the safety and tolerability of ZK 219477 in this patient population<br><br> To assess the impact of the infusion duration on the tolerability of ZK 219477<br> ;<br> Primary end point(s): In patients with measurable disease:<br><br> - Proportion of patients with either CR or PR as best overall response<br><br><br> In patients without measurable disease:<br><br> - Proportion of patients with = 50% reduction in CA-125 levels compared to the<br> pretreatment sample<br>
- Secondary Outcome Measures
Name Time Method