EUCTR2004-004515-26-DE
Active, not recruiting
Not Applicable
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
GYN Research GmbH0 sites100 target enrollmentSeptember 8, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GYN Research GmbH
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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