Approximately 75% of women with ovarian cancer present advanced disease. Survival is highly dependent on the stage of disease at the initiation of treatment. Favorable prognostic factors include young age, cell type other than clear cell or mucinous, lower stage, good performance status, small residual tumor volume after surgery, and absence of ascites. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeks.
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically or cytologically documented evidence of ovarian, primary Fallopian, or primary peritoneal cancer. •WHO Performance Status grade =2 •Life expectancy of =3 months •Taxane/platinum refractory/resistant patients must present with either measurable or non-measurable (evaluable) progressive disease. •Demonstrate the following hematologic lab values within 72 hours prior to administration of study treatment: WBC >3.0x109/L, ANC > 1.5 x 109/L, Hgb > 9g/dL, PLT >100x109/L. •Demonstrate the following blood chemistry lab values within 72 hours prior to administration of study treatment: total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients with CA-125-only disease •Presenting with leptomeningeal involvement •unresolved bowel obstruction •Any peripheral neuropathy > CTC grade 1 •unresolved diarrhea of any grade within last 7 days prior to start of treatment •Prior administration of and/or known hypersensitivity to epothilones •Colostomy •Underlying medical disease(s) that are not controlled •Concomitant administration of any drug/agent known to cause, or increase the severity of, diarrhea •Known, ongoing alcohol and/or drug abuse •Concomitant administration of Coumadin® or other agents containing warfarin • Within 3 weeks of receiving any prior chemotherapy (including consolidation taxane therapy) or who are planning to receive other chemotherapy agents while participating in the study. •Receiving hematopoetic growth factors (except erythropoietin) •Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease. •Not recovered fully from surgery for any cause. •Patients with the presence of active or suspected acute or chronic uncontrolled infection, including abscess or fistulae. •Within 3 weeks of receiving any prior radiotherapy or who are planning to receive radiotherapy while participating in the study •Patients known to be HIV positive •History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or cervical cancer in situ. •Pregnant, breast-feeding, or unwilling to use an acceptable method of contraception (i.e. barrier contraception) while receiving, and for up to 3 months after cessation of, study treatment.. •A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the activity of patupilone administered i. v. once every 3 weeks as defined by overall response rate (complete and partial response) using RECIST Criteria and using CA-125 response for patients with evaluable disease defined by Rustin;Secondary Objective: •To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD). •To determine progression-free survival (PFS) •To determine time to disease progression (TTP) •To determine overall best tumor response (CR, PR, SD, PD and Unknown) •To investigate safety and tolerability of patupilone. •To evaluate the pharmacokinetics (PK) of patupilone •To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/AEs •To assess the incidence and the severity of diarrhea in patients receiving patupilone with intensive management of Chemotherapy-Induced Diarrhea (CID) •To determine the overall survival (OS) •To perform pharmacogenetic analyses with blood samples from patients treated with patupilone as a separate, voluntary study •To investigate tumor-specific mutations and compare gene expression changes in tumor cells with blood cells and plasma for biomarker development;Primary end point(s): The primary efficacy variable is the overall response rate. This is defined as the proportion of patients whose best overall response was complete response (CR) or partial response (PR) | — |
Countries
Austria
Outcome results
None listed