A randomized, 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
- Histologically confirmed high-risk FIGO stage I (grade 3, or aneuploidgrade 1 or 2, or clear cell), or Stages II-IV ovarian epithelial, primaryperitoneal, and fallopian tube cancer.MedDRA version: 8.0Level: HLGTClassification code 10033283
- Registration Number
- EUCTR2004-004333-34-BE
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
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
see inclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether the administration of Erlotinib (maintenance<br>treatment) in patients with ovarian cancer that have achieved either (1) no<br>evidence of disease (2) a response or (3) a stabilization of the disease after<br>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).<br>;Secondary Objective: To determine whether the administration of Erlotinib (maintenance<br>treatment) in patients with ovarian cancer that have achieved either (1) no<br>evidence of disease (2) a response or (3) a stabilization of the disease after<br>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).<br>;Primary end point(s): Progression-free Survival
- Secondary Outcome Measures
Name Time Method