Status:
TERMINATED
Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD)
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ov...
Eligibility Criteria
Inclusion
- Histopathologically documented invasive epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory to platinum-based chemotherapy or with partially platinum sensitive disease.
- Planned therapy with pegylated liposomal doxorubicin 50 mg/m² for recurrent platinum-refractory ovarian cancer.
- Patients with a progression-free-interval of 6 to 12 months after platinum-based chemotherapy are only eligible if a further course of platinum-based combination chemotherapy is not possible as judged by the investigator(s).
- Patients must have received at least one previous platinum- and taxane-based chemotherapy regimen.
Exclusion
- Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
- Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes or induce CYP3A4 function
- Treatment with mouse-antibodies in patients with evaluable disease and CA-125 progressive disease in the last 3 months. These patients are only eligible in case of measurable disease according to RECIST or cytological/histological proven relapse
- More than two prior lines of chemotherapy.
- Any chemotherapy or other systemic anti-cancer therapy within four weeks prior to randomization.
- Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00862836
Start Date
April 1 2009
End Date
September 1 2010
Last Update
October 10 2016
Active Locations (5)
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1
Research Site
Ulm, Baden-Wurttemberg, Germany
2
Research Site
Wiesbaden, Hesse, Germany
3
Research Site
Essen, North Rhine-Westphalia, Germany
4
Research Site
Kiel, Schleswig-Holstein, Germany