Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer

• Status: Completed
• Trial end date: 2009-01-07
• Target enrollment: 0
• Participant gender: Female

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Advanced epithelial Ovarian Cancer (stage IIB-IV)

• Persistent or progressive disease after or relapse within one year of completion of first line therapy

• Measurable or assessable disease

• Eastern Cooperative Oncology Group status less than or equal to 2

Exclusion Criteria:

• History of any other active malignancy

• Signs of CNS metastasis

• More than one prior chemotherapy regimen

• Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks

• First line chemotherapy completed at least 1 month prior to start of treatment