An open-label Phase I/II dose escalation study evaluating the safety and efficacy of patupilone in patients with advanced ovarian, primary fallopian, or primary peritoneal cancer

• Conditions: 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.

• Registration Number: EUCTR2005-004913-14-AT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-07
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 110

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 <1.5 X ULN; AST, ALT <2.5 X ULN (5X ULN where liver metastases are present); Alkaline Phosphatase <5X ULN, serum creatinine =1.5 X ULN.
•No more than one prior taxane/platinum-based combination chemotherapy, a third agent may be included
•Patients must have documented progression of disease within 6 months after receiving at least 4 cycles of the taxane/platinum combination, or must have experienced documented progression of disease while receiving first-line taxane/platinum combination therapy.
•Patients who received consolidation taxane therapy are permitted to enroll in the study if they experienced documented disease progression within 6 months of receiving first-line taxane/platinum combination therapy
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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified