An open-label, multicenter, randomized phase II study to compare the effects of Paclitaxel/Carboplatin and Lonafarnib to those of Paclitaxel/Carboplatin for 1st line treatment of patients with epithelial ovarian cancer FIGO stages IIB-IV
- Conditions
- Female patients with cancer of the ovary, or cancer of the fallopian tube(s), or primary peritoneal cancer
- Registration Number
- EUCTR2004-004515-26-DE
- Lead Sponsor
- GYN Research GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 100
- 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 defined as
WBC > 3.0 x 10 9/lNeutrophils (ANC) >= 1,5 x 10 9/l
Platelets >= 100 x 10 9/lHemoglobin > 6 mmol/l (> 10,0 g/dl)
Bilirubin <= 1 x upper limit of normal range
AST and ALT < 1.5 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 <= 6 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Ovarian tumors of low malignant potential (borderline tumors)
- Non-epithelial ovarian or mixed epithelial/non epithelial 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-CTC 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 have used any investigational drugs within 30 days of study entry
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method