A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer

• Conditions: advanced epithelial ovarian cancer; MedDRA version: 14.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2004-005181-20-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-01
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 810

Inclusion Criteria

1.Histologically confirmed diagnosis of epithelial ovarian, primary fallopian or primary peritoneal cancer. 2. Resistant / refractory to prior taxane and intravenous or intraperitoneal platinum-based chemotherapy (up to three prior regimens) ? Requirements for patients who have received one prior regimen: ? Experienced disease progression during administration of, or within 6 months after administration of at least 4 cycles of one of the following first-line taxane/platinum based combination treatment regimens: ? Initial dose of carboplatin at least AUC 5 - 6 administered IV, or cisplatin at least 75 mg/m2 administered IV, or cisplatin at least 75 mg/m2 administered IP. OR ? Initial dose of cisplatin at least 75 mg/ m2 administered IP, and subsequently switched to an IV therapy with the first dose of at least 75 mg/ m2 (cisplatin) or at least AUC 5 (carboplatin). A third approved therapeutic agent (except anthracyclines) is permitted as part of the initial first line treatment, as a triplet regimen ? Requirements for patients who have received two prior regimens: ? First regimen as described above (see also section 3.3.1.1). ? Second regimen must consist of a platinum salt as a single agent or in combination with either gemcitabine, paclitaxel, docetaxel, cyclophosphamide or topotecan. of at least 4 cycles of second line therapy, or may have experienced toxicity necessitating treatment discontinuation. ? Requirements for patients who have received three prior regimens: ? First regimen as described above (see also section 3.3.1.1). ? Second regimen must consist of either platinum salt, gemcitabine, docetaxel, paclitaxel, cyclophosphamide or topotecan, administered as a single agent or in combination therapy. ? Third regimen must consist of a platinum salt as a single agent or in combination with either gemcitabine, paclitaxel, cyclophosphamide or topotecan. Patients must have documented progression of disease during or within 6 months after the last dose of at least 4 cycles of third line therapy or may have experienced toxicity necessitating treatment discontinuation. ? Patients treated with one taxane platinum-based regimen as a neo-adjuvant treatment and one other taxane-platinum-based regimen as an adjuvant therapy should be considered as having received only one regimen, providing that the adjuvant chemotherapy is initiated within 4 month after the completion of the neo-adjuvant therapy. ? Patients who received consolidation and/or maintenance therapy with an approved agent are eligible provide that disease progression is documented within 6 months after the last dose of platinum-based chemotherapy. See protocolo for a complete list of inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

1. Patients with CA-125-only disease. 2. Unresolved bowel obstruction. 3. Not recovered fully from surgery for any cause. 4. Prior administration of epothilones, anthracyclines (including doxorubicin, epirubicin, daunorubicin, mitoxantrone), and/or pegylated liposomal doxorubicin. 5. 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. 6. Within 3 weeks of receiving any prior radiotherapy or who are planning to receive radiotherapy while participating in the study. (Exception: Palliative radiotherapy of metastasis in extremities is allowed, but such lesions cannot be used as target lesions.) 7. Received any investigational compound within the past 28 days or who are planning to receive other investigational drugs while participating in the study. 8. Date of first study treatment would be more than 30 days past the screening CT scan (Screening CT scan must be performed within 6 months from last date of platinum-based chemotherapy) confirming disease progression. 9. Any peripheral neuropathy > CTC grade 1. 10. Unresolved diarrhea of any grade within last 7 days prior to start of treatment. 11. Presenting with symptomatic brain metastasis and/or leptomeningeal involvement. 12. Colostomy. 13. Underlying medical disease(s) that are not controlled [e.g. uncontrolled non-insulin dependant diabetes mellitus (NIDDM)]. 14. Known HIV positive status, and/or with the presence of an active or suspected acute or chronic uncontrolled infection. 15. Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease. 16. History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or cervical cancer in situ. 17. Receiving hematopoietic growth factors (except erythropoietin). 18. Concomitant administration of Coumadin or other agents containing warfarin, with the exception of low dose Coumadin (1 mg or less daily) administered prophylactically for maintenance of in-dwelling lines or ports. (Wash-out period from therapeutic dose of Coumadin should be ≥ 7 days). See protocol for complete list of exclusion criteria.

Study & Design

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