Epithelial Ovarian Cancer, First-Line Treatment Cancer Ovarian
Conditions
Interventions
Paclitaxel/Carboplatin +/- Lonafarnib
The previous sponsor for this trial (until November 2009) was:
MedServ. GmbH (Germany)
Ludwig-Erhard-Str. 100,
65199 Wiesbaden
Germany
Sponsors
AGO Research GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previously untreated patients with a histologically confirmed diagnosis of cancer of the ovary or the fallopian tube or extra-ovarian papillary serous tumors FIGO stage IIB?IV regardless of measurable or non-measurable disease 2. Age =18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status =2 4. Life-expectancy of at least 6 months 5. Adequate bone marrow, renal and hepatic function defined as white blood cell count (WBC) >3.0/nl, Neutrophils (ANC) =1.5/nl, Platelets =100/nl, Hemoglobin >6 mmol/l (>10.0 g/dl), Bilirubin =1 x upper limit of normal range 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5 x upper limit of normal range 7. Alkaline phosphatase <2.5 x upper limit of normal range 8. Estimated glomerular filtration rate GFR =50 ml/min according to Jelliffe or Cockroft-Gault formula 9. Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication and constraints of the protocol 10. Patients must be geographically accessible for treatment and follow-up 11. Time between definitive surgery and randomization =6 weeks
Exclusion criteria
Exclusion criteria: 1. Ovarian tumors of low malignant potential (borderline tumors 2. Non-epithelial ovarian or mixed epithelial/non epithelial tumors (e.g. mixed Mullerian tumors) 3. Patients who have received previous chemotherapy or radiotherapy 4. Prior treatment with FT inhibitors 5. Patients with a prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) 6. Complete bowel obstruction or the presence of symptomatic brain metastases 7. Concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy 8. Patients with a history of seizure disorder or central nervous system disorders 9. Pre-existing motor or sensory neurologic pathology or symptoms >National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grade 1 10. History of congestive heart failure (New York Heart Association [NYHA] Classification >2), even if medically controlled 11. History of clinical and electrocardiographically documented myocardial infarction within the last 6 months 12. History of atrial or ventricular arrhythmias (=LOWN II) 13. Patients with significant Fridericia QTc (QTcF) prolongation at Baseline (i.e. QTcF >470 msec) 14. Patients with severe active infection 15. Patients with a history of severe hypersensitivity reactions to products containing Cremophor EL (cyclosporin or vitamin K) and/or patients with known hypersensitivity to compounds chemically related to Carboplatin and Paclitaxel 16. Fertile women not using adequate contraceptive methods 17. Women who are pregnant or breast feeding 18. Administration of other anticancer therapy or simultaneous chemotherapeutic and/or hormonal drugs, or radiotherapy during the study treatment period (except: hormonal replacement therapy and/or steroid antiemetics) 19. Patients who have used any investigational drugs within 30 days of study entry 20. Patients who are participating in any other clinical study 21. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the effect (progression-free survival [PFS]) of paclitaxel/carboplatin and lonafarnib to that of paclitaxel/carboplatin in patients with previously untreated epithelial cancer of the ovary FIGO stages IIB?IV. The primary purpose of this study is to determine whether the additional effect of lonafarnib is sufficient to conduct a phase III study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to evaluate response to treatment and overall survival, and to assess the safety in both treatment arms and to assess exposure (PK) and PD of lonafarnib. | — |
Countries
Germany
Outcome results
None listed