Ovarian Cancer Clinical Trial
Official title:
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
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Sometimes after treatment, the tumor may not need additional
treatment until it progresses. In this case, observation may be sufficient. It is not yet
known whether erlotinib is more effective than observation after first-line chemotherapy in
treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works
compared to observation in treating patients who have undergone first-line chemotherapy for
ovarian cancer, peritoneal cancer, or fallopian tube cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
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