Comparison of Paclitaxel/Carboplatin and Lonafarnib to Paclitaxel/Carboplatin for First-line Treatment of Ovarian Cancer
NCT ID: NCT00281515
Last Updated: 2012-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2006-01-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Lonafarnib / Paclitaxel /Carboplatin
Lonafarnib
100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day
Paclitaxel/Carboplatin
Standard Chemotherapy
Lonafarnib
100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day
Interventions
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Lonafarnib
100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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AGO Study Group
OTHER
Responsible Party
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Principal Investigators
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Werner Meier, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Ev. Krankenhaus, Düsseldorf, Germany
Locations
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Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
Berlin, , Germany
Klinikum Bremen Mitte, Frauenklinik
Bremen, , Germany
Carl-Gustav-Carus der TU Dresden, Universitäts-Frauenklinik
Dresden, , Germany
Ev. Krankenhaus, Frauenklinik
Düsseldorf, , Germany
Klinik für Frauenheilkunde der Univ. Erlangen
Erlangen, , Germany
Universitätsfrauenklinik
Essen, , Germany
Klinikum der Johann Wolfgang Goethe Universität, Klinik für Frauenheilkunde u. Geburtshilfe
Frankfurt, , Germany
Universitätsklinikum Freiburg, Frauenklinik
Freiburg im Breisgau, , Germany
Kreiskrankenhaus, Frauenklinik
Gifhorn, , Germany
Klinik u. Poliklinik für Gynäkologie und Geburtshilfe
Greifswald, , Germany
Medizinische Hochschule
Hanover, , Germany
St. Vincentius-Krankenhäuser
Karlsruhe, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynäkologie und Geburtshilfe
Kiel, , Germany
Klinik der Otto-von-Guericke Universität, Frauenklinik
Magdeburg, , Germany
Johannes-Gutenberg-Universität, Universitäts-Frauenklinik
Mainz, , Germany
Klinikum der Philipps-Universität Marburg, Klinik für Gynäkologie, Gynäkologische Endokrinologie
Marburg, , Germany
Klinikum Großhadern, Frauenklinik
München, , Germany
Klinikum rechts der Isar der TU München
München, , Germany
Elblandkliniken, Frauenklinik
Radebeul, , Germany
Klinikum Südstadt
Rostock, , Germany
Universitäts-Frauenklinik
Tübingen, , Germany
Universitätsfrauenklinik
Ulm, , Germany
Dr. Horst Schmidt Klinik, Gynäkologie u. Gynäkologische Onkologie
Wiesbaden, , Germany
Countries
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References
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Meier W, du Bois A, Rau J, Gropp-Meier M, Baumann K, Huober J, Wollschlaeger K, Kreienberg R, Canzler U, Schmalfeldt B, Wimberger P, Richter B, Schroder W, Belau A, Stahle A, Burges A, Sehouli J. Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV. Gynecol Oncol. 2012 Aug;126(2):236-40. doi: 10.1016/j.ygyno.2012.04.050. Epub 2012 May 4.
Other Identifiers
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AGO-OVAR 15
Identifier Type: -
Identifier Source: org_study_id