Comparison of Paclitaxel/Carboplatin and Lonafarnib to Paclitaxel/Carboplatin for First-line Treatment of Ovarian Cancer
An Open-label, Multicenter, Randomized Phase II Study to Compare the Effects of Paclitaxel/Carboplatin and Lonafarnib to Those of Paclitaxel/Carboplatin for First-line Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages IIB-IV
1 other identifier
interventional
105
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2006
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 24, 2006
CompletedFirst Posted
Study publicly available on registry
January 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 29, 2012
June 1, 2012
5.9 years
January 24, 2006
June 28, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
every 3 months until PD
Secondary Outcomes (6)
Objective tumor response rate (CR/PR (RECIST))
During whole trial
Duration of response
Until Progression of disease
Overall survival
Until date of death
safety based on nature, frequency and severity of adverse events
During treatment phase until resolution
Predose lonafarnib concentrations
During treatment
- +1 more secondary outcomes
Study Arms (2)
Lonafarnib / Paclitaxel /Carboplatin
EXPERIMENTALPaclitaxel/Carboplatin
OTHERStandard Chemotherapy
Interventions
100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AGO Study Grouplead
Study Sites (23)
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
Berlin, 13353, Germany
Klinikum Bremen Mitte, Frauenklinik
Bremen, 28177, Germany
Carl-Gustav-Carus der TU Dresden, Universitäts-Frauenklinik
Dresden, 01307, Germany
Ev. Krankenhaus, Frauenklinik
Düsseldorf, 40217, Germany
Klinik für Frauenheilkunde der Univ. Erlangen
Erlangen, 91054, Germany
Universitätsfrauenklinik
Essen, 45147, Germany
Klinikum der Johann Wolfgang Goethe Universität, Klinik für Frauenheilkunde u. Geburtshilfe
Frankfurt, 60590, Germany
Universitätsklinikum Freiburg, Frauenklinik
Freiburg im Breisgau, 79106, Germany
Kreiskrankenhaus, Frauenklinik
Gifhorn, 38518, Germany
Klinik u. Poliklinik für Gynäkologie und Geburtshilfe
Greifswald, 17487, Germany
Medizinische Hochschule
Hanover, 30625, Germany
St. Vincentius-Krankenhäuser
Karlsruhe, 76137, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynäkologie und Geburtshilfe
Kiel, 24105, Germany
Klinik der Otto-von-Guericke Universität, Frauenklinik
Magdeburg, 39108, Germany
Johannes-Gutenberg-Universität, Universitäts-Frauenklinik
Mainz, 55101, Germany
Klinikum der Philipps-Universität Marburg, Klinik für Gynäkologie, Gynäkologische Endokrinologie
Marburg, 35037, Germany
Klinikum Großhadern, Frauenklinik
München, 81377, Germany
Klinikum rechts der Isar der TU München
München, 81675, Germany
Elblandkliniken, Frauenklinik
Radebeul, 01445, Germany
Klinikum Südstadt
Rostock, 18059, Germany
Universitäts-Frauenklinik
Tübingen, 72076, Germany
Universitätsfrauenklinik
Ulm, 89075, Germany
Dr. Horst Schmidt Klinik, Gynäkologie u. Gynäkologische Onkologie
Wiesbaden, 65199, Germany
Related Publications (1)
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.
PMID: 22564713RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Werner Meier, Prof. Dr.
Ev. Krankenhaus, Düsseldorf, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2006
First Posted
January 25, 2006
Study Start
January 1, 2006
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
June 29, 2012
Record last verified: 2012-06