E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10033283 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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).
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E.2.2 | Secondary objectives of the trial |
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).
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. 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 OV13) is allowed, as is interval debulking surgery after 3 cycles of chemotherapy and second-look surgery at the end of the chemotherapy. |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free Survival |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard approach - observation alone |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study occurs when all of the following criteria have been satisfied: 1. Thirty days after all patients have stopped protocol treatment 2. The trial is mature for the analysis of the primary endpoint as defined in the protocol 3. The database has been fully cleaned and frozen for this analysis |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |