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Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).

Outcome Description:

Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)

Outcome Time Frame:

From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.

Safety Issue:

Yes

Authority:

Germany: Ethics Commission

Study ID:

D4200C00083

NCT ID:

NCT00862836

Start Date:

April 2009

Completion Date:

September 2010

Related Keywords:

  • Ovarian Cancer
  • ZD6474
  • Vandetanib
  • Zactima
  • Ovarian Cancer
  • Phase I
  • Phase II
  • Randomized
  • Safety
  • Ovarian Neoplasms

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