Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD) (ZACFAST)

Genzyme

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Ovarian Cancer

Treatments: Drug: Vandetanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862836

2008-005557-38 (EudraCT Number)

D4200C00083

Details and patient eligibility

About

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 ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

1

Experimental group

Description:

Vandetanib added to standard therapy (pegliposomal doxorubicin)

Treatment:

Drug: Vandetanib