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

Sponsor
AGO Study Group (Other)
Overall Status
Completed
CT.gov ID
NCT00281515
Collaborator
(none)
105
Enrollment
23
Locations
2
Arms
71
Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [every 3 months until PD]

Secondary Outcome Measures

  1. Objective tumor response rate (CR/PR (RECIST)) [During whole trial]

  2. Duration of response [Until Progression of disease]

  3. Overall survival [Until date of death]

  4. safety based on nature, frequency and severity of adverse events [During treatment phase until resolution]

  5. Predose lonafarnib concentrations [During treatment]

  6. PD activity [Assessment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 109/l; Neutrophils (ANC) >= 1.5 x 109/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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde Berlin Germany 13353
2 Klinikum Bremen Mitte, Frauenklinik Bremen Germany 28177
3 Carl-Gustav-Carus der TU Dresden, Universitäts-Frauenklinik Dresden Germany 01307
4 Ev. Krankenhaus, Frauenklinik Düsseldorf Germany 40217
5 Klinik für Frauenheilkunde der Univ. Erlangen Erlangen Germany 91054
6 Universitätsfrauenklinik Essen Germany 45147
7 Klinikum der Johann Wolfgang Goethe Universität, Klinik für Frauenheilkunde u. Geburtshilfe Frankfurt Germany 60590
8 Universitätsklinikum Freiburg, Frauenklinik Freiburg Germany 79106
9 Kreiskrankenhaus, Frauenklinik Gifhorn Germany 38518
10 Klinik u. Poliklinik für Gynäkologie und Geburtshilfe Greifswald Germany 17487
11 Medizinische Hochschule Hannover Germany 30625
12 St. Vincentius-Krankenhäuser Karlsruhe Germany 76137
13 Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynäkologie und Geburtshilfe Kiel Germany 24105
14 Klinik der Otto-von-Guericke Universität, Frauenklinik Magdeburg Germany 39108
15 Johannes-Gutenberg-Universität, Universitäts-Frauenklinik Mainz Germany 55101
16 Klinikum der Philipps-Universität Marburg, Klinik für Gynäkologie, Gynäkologische Endokrinologie Marburg Germany 35037
17 Klinikum Großhadern, Frauenklinik München Germany 81377
18 Klinikum rechts der Isar der TU München München Germany 81675
19 Elblandkliniken, Frauenklinik Radebeul Germany 01445
20 Klinikum Südstadt Rostock Germany 18059
21 Universitäts-Frauenklinik Tübingen Germany 72076
22 Universitätsfrauenklinik Ulm Germany 89075
23 Dr. Horst Schmidt Klinik, Gynäkologie u. Gynäkologische Onkologie Wiesbaden Germany 65199

Sponsors and Collaborators

  • AGO Study Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AGO Study Group
ClinicalTrials.gov Identifier:
NCT00281515
Other Study ID Numbers:
  • AGO-OVAR 15
First Posted:
Jan 25, 2006
Last Update Posted:
Jun 29, 2012
Last Verified:
Jun 1, 2012
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Lonafarnib

Study Results

No Results Posted as of Jun 29, 2012