Randomized, Multicenter, 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 16 mg/m2) in Patients With Recurrent Ovarian Cancer Progressing During, or Within 6 Months of the End of Platinum-Based Chemotherapy
18 Years
N/A
Female
Ovarian Neoplasms
Trial Information
Randomized, Multicenter, 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 16 mg/m2) in Patients With Recurrent Ovarian Cancer Progressing During, or Within 6 Months of the End of Platinum-Based Chemotherapy
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Inclusion Criteria:
- Females aged 18 or over
- Cancer of any of the following types:
- epithelial ovarian cancer
- peritoneal cavity cancer
- fallopian tube cancer
- Up to 2 previous chemotherapies; the most recent must have been a platinum-
containing therapy
- Progression of disease or symptomatic relapse during, or within 6 months of previous
therapy
- 4 weeks or more since prior radiotherapy or chemotherapy
- 3 weeks or more since prior immunotherapy
- Adequate recovery from previous surgery, radiotherapy, and chemotherapy ( excluding
alopecia)
- Survival expectation of 3 months or more
Exclusion Criteria:
- More than 2 previous chemotherapies
- Previous treatment with epothilones
- Use of any investigational drug within 4 weeks of start of study treatment or
inadequate recovery from any toxic effects of such therapy
- Previous radiation to the whole pelvis
- Symptomatic brain metastases requiring whole-brain irradiation
- Active infection
- Any other malignancy except:
- Non-melanoma skin cancer
- Carcinoma in situ of cervix
- Malignancy with treatment 5 or more years ago without relapse
- Mixed mesodermal tumor
- Prior hormone therapy for any malignancy in the previous month
- Women of childbearing potential
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of responders
Outcome Time Frame:
18 weeks
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
91447
NCT ID:
NCT00246688
Start Date:
November 2005
Completion Date:
June 2007
Related Keywords:
- Ovarian Neoplasms
- Neoplasms
- Ovarian Neoplasms
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