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

• Conditions: Taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer.; MedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancer

• Registration Number: EUCTR2004-005181-20-IE
• Lead Sponsor: ovartis Pharmaceuticals Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-15
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion criteria
Each subject must meet all of the following inclusion criteria at screening in order to be enrolled in the study:
1. Histologically confirmed diagnosis of epithelial ovarian, primary fallopian or primary
peritoneal cancer. Eligible histologies include:
• Serous adenocarcinoma
• Endometrioid adenocarcinoma
• Mucinous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Transitional cell carcinoma
• Malignant Brenner's Tumor
• Adenocarcinoma NOS
2. Resistant / refractory to prior 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 completing at least 4 cycles of, either 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 100mg/m2 administered IP.
OR
• Initial dose of cisplatin at least 100 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 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, cyclophosphamide or topotecan.
• Patients must have documented disease progression during or within 6 months
after receiving 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 carboplatin, cisplatin, gemcitabine,
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 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 may have received consolidation therapy with an approved agent and
experienced documented disease progression within 6 months after the last dose of
platinum-based chemotherapy
3. Taxane/platinum refractory/resistant patients must present with either measurable or nonmeasurable
progressive disease.
1. Patients with measurable disease:
• Measurable disease as defined by RECIST criteria: CT scans (with 10 mm sliced
cuts) or NMRI scan lesion size of = 2 cm (or = 1 cm via spiral CT), with
documented disease progression. Disease measurement must be taken within 30
days prior to start of treatment.
• Measurable disease pr

Exclusion Criteria

Exclusion criteria
Subjects with, or meeting, any one of the following criteria during screening will be excluded from entry into the study:
1. Patients with CA-125-only disease.
2. Unresolved bowel obstruction.
3. Not recovered fully from surgery for any cause.
4. Prior administration of and/or known hypersensitivity to: 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 most recent date of confirmed 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 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.
19. Concomitant administration of any drug/agent known to cause, or increase the severity of, diarrhea. Patients must cease treatment with any such agents at least 7 days prior to start of study treatment.
20. Concomitant administration of any drug/agent known to interact negatively with
doxorubicin or pegylated liposomal doxorubicin.
21. Known, ongoing alcohol and/or drug abuse.
22. A history of noncompliance to medical regimens or inability or unwillingness to return to the study center for scheduled visits, including tumor assessments and blood draws.
23. 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.

Study & Design

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