Histologically confirmed high-risk FIGO stage I (grade 3, or aneuploid grade 1 or 2, or clear cell), or Stages II-IV ovarian epithelial, primary peritoneal, and fallopian tube cancer. MedDRA version: 8.0 Level: HLGT Classification code 10033283
Conditions
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed high-risk FIGO stage I (grade 3, or aneuploid grade 1 or 2, or clear cell), or Stages II-IV ovarian epithelial, primary peritoneal, and fallopian tube cancer. 2. No adenocarcinoma of unknown origin. 3. No more than 6 weeks since the end (considering the end the day 21 [D21] of the last cycle)of first line therapy for ovarian cancer. First line therapy should include 6-9 cycles (as per institutional policy) of a platinum derivative alone or in combination with other agents. Accepted doses for the platinum agent are: a) Carboplatin at a minimal dose of AUC 5/3weeks when using EDTA clearance or calculated GFR (however, when using calculated GFR a minimal dose of AUC 6/3weeks is recommended), or b) Cisplatin initially scheduled at = 60 mg/m2/3weeks). 4. 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 therapy, as assessed according to the RECIST criteria35 and/or to the GCIG criteria in case of CA125-based evaluation36 at the end of first line therapy. 5. Age over 18 years. 6. ECOG 0-1. 7. Adequate bone marrow, hepatic and renal functions (within 14 days before first day of study treatment): ? Absolute white blood cell count = 2.0 x 109/l. ? Absolute platelet count = 100 x 109/l. ? Serum total bilirubin = 1.5 x UNL. ? ASAT and ALAT = 2.5 x UNL in patients of no known liver metastases; = 5 x UNL in patients with known liver metastases. ? Alkaline phosphatase = 5 x UNL, except in patients with known bone metastases. ? PT, PTT = 1-1.5 UNL (gr. 1 CTCAE v3.0) ? Serum Creatinine = 2.0 x UNL. 8. No prior or concurrent treatment with any other investigational agent. 9. No prior therapy targeting the epidermal growth factor receptor. 10. No prior allergic reaction to any compound chemically related to the study drug. 11. No previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. 12. No known history of brain metastases and/or leptomeningeal disease. 13. No gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation or affecting absorption. No active peptic ulcer disease. 14. No uncontrolled bowel inflammatory disease (e.g., Crohn´s disease or ulcerative colitis). 15. No myocardial infarction within the past 6 months. 16. No second- or third-degree heart blocks unless pacemaker implanted. 17. No significant dermatological disease. 18. No inflammatory changes of the surface of the eye 19. No other significant medical condition, neurological or psychiatric disorder. 20. No pregnant or lactating women (or potentially fertile women not using adequate contraception). 21. No prior radiotherapy. However, any radiotherapy more than 5 years ago and outside the abdomen/pelvis is permitted. 22. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 23. Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations Patients can only be randomized in this trial once. NB: Double randomization in the neoadjuvant versus primary debulking surgery (EORTC 55971/NCIC OV
Exclusion criteria
Exclusion criteria: see inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the administration of Erlotinib (maintenance treatment) in patients with ovarian cancer that have achieved either (1) no evidence of disease (2) a response or (3) a stabilization of the disease after first line, platinum-based chemotherapy benefits this subset of patients in terms of progression-free survival (compared with the standard approach, that consists in observation alone). ;Secondary Objective: To determine whether the administration of Erlotinib (maintenance treatment) in patients with ovarian cancer that have achieved either (1) no evidence of disease (2) a response or (3) a stabilization of the disease after first line, platinum-based chemotherapy benefits this subset of patients in terms of overall survival, safety, and quality of life (compared with the standard approach, that consists in observation alone). ;Primary end point(s): Progression-free Survival | — |
Countries
Austria, Belgium, Italy, Spain, United Kingdom
Outcome results
None listed