A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
- Compare the benefits, in terms of progression-free survival, of maintenance therapy
comprising erlotinib vs observation in patients with responding or stable disease after
first-line, platinum-based chemotherapy for high-risk stage I or stage II-IV ovarian
epithelial, primary peritoneal, or fallopian tube cancer.
- Compare the overall survival of patients treated with these regimens.
- Determine the safety of erlotinib in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (I-II vs III-IV), participating center, age (≤ 65 vs > 65), response to
first-line therapy (no evidence of disease/complete response vs partial response vs stable
disease), and first-line therapy (platinum-based vs platinum/taxane combination vs
platinum-based triplet). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral erlotinib once daily for up to 2 years in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation as per standard of care. Quality of life is
assessed at baseline and then every 3 months for up to 2 years.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 830 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Hospital Universitario 12 de Octubre
United States: Federal Government