A Phase 3 interventional study of erlotinib hydrochloride in Fallopian Tube Cancer, Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 92 sites in 8 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-27.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment
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
Secondary
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.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 830 patients will be accrued for this study.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 835 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer meeting 1 of the following criteria:
Completed first-line therapy within the past 6 weeks
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Progression-free survival
Overall survival
Adverse event profile
Quality of life
Cutaneous toxicity (rash or acne [papulo-pustular rash])
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC