Comparison of Paclitaxel/Carboplatin and Lonafarnib to Paclitaxel/Carboplatin for First-line Treatment of Ovarian Cancer

June 28, 2012 updated by: AGO Study Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 tumor cell lines in vitro and tumor xenografts in nude mice. Lonafarnib has single-agent antitumor activity as well as enhanced activity in combination with taxanes in a number of tumor cell lines and in vivo models.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
      • Bremen, Germany, 28177
        • Klinikum Bremen Mitte, Frauenklinik
      • Dresden, Germany, 01307
        • Carl-Gustav-Carus der TU Dresden, Universitäts-Frauenklinik
      • Düsseldorf, Germany, 40217
        • Ev. Krankenhaus, Frauenklinik
      • Erlangen, Germany, 91054
        • Klinik für Frauenheilkunde der Univ. Erlangen
      • Essen, Germany, 45147
        • Universitätsfrauenklinik
      • Frankfurt, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe Universität, Klinik für Frauenheilkunde u. Geburtshilfe
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg, Frauenklinik
      • Gifhorn, Germany, 38518
        • Kreiskrankenhaus, Frauenklinik
      • Greifswald, Germany, 17487
        • Klinik u. Poliklinik für Gynäkologie und Geburtshilfe
      • Hannover, Germany, 30625
        • Medizinische Hochschule
      • Karlsruhe, Germany, 76137
        • St. Vincentius-Krankenhäuser
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynakologie und Geburtshilfe
      • Magdeburg, Germany, 39108
        • Klinik der Otto-von-Guericke Universität, Frauenklinik
      • Mainz, Germany, 55101
        • Johannes-Gutenberg-Universität, Universitäts-Frauenklinik
      • Marburg, Germany, 35037
        • Klinikum der Philipps-Universität Marburg, Klinik für Gynäkologie, Gynäkologische Endokrinologie
      • München, Germany, 81675
        • Klinikum Rechts der Isar der TU München
      • München, Germany, 81377
        • Klinikum Großhadern, Frauenklinik
      • Radebeul, Germany, 01445
        • Elblandkliniken, Frauenklinik
      • Rostock, Germany, 18059
        • Klinikum Südstadt
      • Tübingen, Germany, 72076
        • Universitäts-Frauenklinik
      • Ulm, Germany, 89075
        • Universitätsfrauenklinik
      • Wiesbaden, Germany, 65199
        • Dr. Horst Schmidt Klinik, Gynäkologie u. Gynäkologische Onkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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:

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lonafarnib / Paclitaxel /Carboplatin
Drug: Lonafarnib
100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day
Other: Paclitaxel/Carboplatin
Standard Chemotherapy
Drug: Lonafarnib
100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: every 3 months until PD
every 3 months until PD

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective tumor response rate (CR/PR (RECIST))
Time Frame: During whole trial
During whole trial
Duration of response
Time Frame: Until Progression of disease
Until Progression of disease
Overall survival
Time Frame: Until date of death
Until date of death
safety based on nature, frequency and severity of adverse events
Time Frame: During treatment phase until resolution
During treatment phase until resolution
Predose lonafarnib concentrations
Time Frame: During treatment
During treatment
PD activity
Time Frame: Assessment
Assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGO Study Group

Investigators

  • Principal Investigator: Werner Meier, Prof. Dr., Ev. Krankenhaus, Düsseldorf, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 24, 2006

First Submitted That Met QC Criteria

January 24, 2006

First Posted (Estimate)

January 25, 2006

Study Record Updates

Last Update Posted (Estimate)

June 29, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGO-OVAR 15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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