TARCEVA: A randomised, multicentre, phase III study of Erlotinib versus observation in patients with no evidence of disease progression after first line, platinum-based chemotherapy for high-risk Stage I and Stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
- Conditions
- Ovarian epithelial, primary peritoneal, or fallopian tube cancerCancer - Ovarian and primary peritoneal
- Registration Number
- ACTRN12607000071426
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 830
1.Histologically confirmed high-risk International Federation of Gynecology and Obstetrics (FIGO) stage I (grade 3, or aneuploid grade 1 or 2, or clear cell), or stage II-IV ovarian epithelial, primary peritoneal, and fallopian tube cancer.2.Complete response (CR) (clinical and/or pathological, i.e., no evidence of disease [NED] status), partial response (PR), or disease stabilization (SD) after first line therapy3. Eastern Cooperative Oncology Group (ECOG) 0-1. 4. Randomisation within 6 weeks of the end of first line therapy for ovarian cancer (Carboplatin or Cisplatin). 5.Adequate bone marrow, hepatic and renal functions. 6.Written informed consent.
1.Adenocarcinoma of unknown origin.2.Prior or concurrent treatment with any other investigational agent3.Prior therapy targeting the epidermal growth factor receptor (EGFR)4.Prior allergic reaction to any compound chemically related to the study drug5.Previous (within the last 5 years) or concurrent malignancies6.Known history of brain metastases and/or leptomeningeal disease.7.Gastrointestinal tract disease resulting in an inability to take oral medication or requiring parenteral nutrition or affecting absorption. Active peptic ulcer disease.8.Uncontrolled bowel inflammatory disease (e.g., Crohn´s disease or ulcerative colitis).9.Myocardial infarction within the past 6 months.10.Second- or third-degree heart blocks unless pacemaker implanted.11.Significant dermatological disease.12.Inflammatory changes of the surface of the eye.13.Other significant medical condition, neurological or psychiatric disorder.14.Pregnant or lactating women (or potentially fertile women not using adequate contraception).15.Prior radiotherapy.16.Any condition potentially hampering compliance with the study protocol and follow-up schedule.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival[Measured as clinically indicated during treatment/observation or follow-up, and at the end of treatment/observation, until recurrence. Abdominal and pelvic Computed tomography (CT) scans and chest X-ray will be performed when clinically indicated, when progression is suspected either clinically or by CA125 monitoring, or at the discretion of the treating physician.]
- Secondary Outcome Measures
Name Time Method Overall Survival[Measured from randomisation];Adverse event profile[Measured every 3 months during treatment/observation and at follow-up (follow-up at least every 3 months during the first and second year, every 4 months in the 3rd and 4th year, every 6 months the 5th year and thereafter once every year until death)];Quality of Life (QoL)[Measured pre-treatment and every 3 months during treatment/observation.];Cutaneous toxicity [rash or acne (papulo-pustular rash)][Measured every 3 months during treatment/observation and at follow-up (follow-up at least every 3 months during the first and second year, every 4 months in the 3rd and 4th year, every 6 months the 5th year and thereafter once every year until death.)]