Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian Cancer

NCT00246688CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Bayer

Enrollment

63

Start Date

2005-11-01

Completion Date

2007-06-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Sagopilone (BAY86-5302ZK219477)

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Proportion of responders

Time frame: 18 weeks

Secondary Outcomes

Duration of response

Time frame: up to 1 year after LPLTV

Time to disease progression

Time frame: up to 1 year after LPLTV

Number of participants with adverse events

Time frame: Approximately 30 weeks