Status:
COMPLETED
Comparison of Paclitaxel/Carboplatin and Lonafarnib to Paclitaxel/Carboplatin for First-line Treatment of Ovarian Cancer
Lead Sponsor:
AGO Study Group
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the effects of Paclitaxel/Carboplatin and Lonafarnib to those of Paclitaxel/Carboplatin in primary treatment of patients with epithelial ovarian cancer.
Detailed Description
Today the standard therapy for patients with advanced ovarian carcinoma is paclitaxel and carboplatin. Lonafarnib is a farnesyl transferase inhibitor (FTI) that is active against a broad spectrum of t...
Eligibility Criteria
Inclusion
- Previously untreated patients with a histologically confirmed diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors FIGO stage IIB-IV, regardless of measurable or non-measurable disease
- Age \>= 18 years
- ECOG performance status \<= 2
- Life-expectancy of at least 6 months
- Adequate bone marrow, renal and hepatic function:
- WBC \>= 3.0 x 10\^9/l; Neutrophils (ANC) \>= 1.5 x 10\^9/l; Platelets \>= 100 x 10\^9/l; Hemoglobin \> 6 mmol/l (\> 10.0 g/dl); Bilirubin \<= 1 x upper limit of normal range; Alkaline phosphatase \<= 2.5 x upper limit of normal range; estimated GFR \>= 50 ml/min according to Jelliffe or Cockroft-Gault formula
- 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
- Patients must be geographically accessible for treatment and follow-up
- Time between definitive surgery and randomization into the study \<= 6 weeks
Exclusion
- Ovarian tumors of low malignant potential (borderline tumors)
- Non-epithelial ovarian or mixed epithelial/nonepithelial tumors (e.g. Mixed Mullerian tumors)
- Patients who have received previous chemotherapy or radiotherapy
- Prior treatment with FT inhibitors
- 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)
- Complete bowel obstruction or the presence of symptomatic brain metastases
- 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
- Patients with a history of seizure disorder or central nervous system disorders; pre-existing motor or sensory neurologic pathology or symptoms \> NCI grade 1
- History of congestive heart failure (NYHA Classification \> 2, even if medically controlled.
- History of clinical and electrocardiographically documented myocardial infarction within the last 6 months.
- History of atrial or ventricular arrhythmias (\>= LOWN II)
- Patients with significant Fridericia QTc (QTcF) prolongation at Baseline (ie. QTcF \>= 470 msec)
- Patients with severe active infection
- 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
- Women with childbearing potential and who are sexually active and unwilling to use a medically acceptable method of contraception (oral contraceptive, diaphragm with spermicide, intrauterine device, condom with spermicide)
- Women who are pregnant or breast feeding
- 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)
- Patients who are participating in any other clinical study
- Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00281515
Start Date
January 1 2006
End Date
December 1 2011
Last Update
June 29 2012
Active Locations (23)
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1
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
Berlin, Germany, 13353
2
Klinikum Bremen Mitte, Frauenklinik
Bremen, Germany, 28177
3
Carl-Gustav-Carus der TU Dresden, Universitäts-Frauenklinik
Dresden, Germany, 01307
4
Ev. Krankenhaus, Frauenklinik
Düsseldorf, Germany, 40217