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Epithelial Ovarian CancerPhase 2NCT00281515

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

A Phase 2 study testing Lonafarnib in people with Epithelial Ovarian Cancer, run by AGO Study Group at 23 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
Lonafarnib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
23 sitesGermany
Study dates
Jan 2006to Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde

    Berlin, 13353

  • Klinikum Bremen Mitte, Frauenklinik

    Bremen, 28177

  • Carl-Gustav-Carus der TU Dresden, Universitäts-Frauenklinik

    Dresden, 01307

  • Ev. Krankenhaus, Frauenklinik

    Düsseldorf, 40217

  • Klinik für Frauenheilkunde der Univ. Erlangen

    Erlangen, 91054

  • Universitätsfrauenklinik

    Essen, 45147

  • Klinikum der Johann Wolfgang Goethe Universität, Klinik für Frauenheilkunde u. Geburtshilfe

    Frankfurt, 60590

  • Universitätsklinikum Freiburg, Frauenklinik

    Freiburg im Breisgau, 79106

  • Kreiskrankenhaus, Frauenklinik

    Gifhorn, 38518

  • Klinik u. Poliklinik für Gynäkologie und Geburtshilfe

    Greifswald, 17487

  • Medizinische Hochschule

    Hanover, 30625

  • St. Vincentius-Krankenhäuser

    Karlsruhe, 76137

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynäkologie und Geburtshilfe

    Kiel, 24105

  • Klinik der Otto-von-Guericke Universität, Frauenklinik

    Magdeburg, 39108

  • Johannes-Gutenberg-Universität, Universitäts-Frauenklinik

    Mainz, 55101

  • Klinikum der Philipps-Universität Marburg, Klinik für Gynäkologie, Gynäkologische Endokrinologie

    Marburg, 35037

  • Klinikum Großhadern, Frauenklinik

    München, 81377

  • Klinikum rechts der Isar der TU München

    München, 81675

  • Elblandkliniken, Frauenklinik

    Radebeul, 01445

  • Klinikum Südstadt

    Rostock, 18059

  • Universitäts-Frauenklinik

    Tübingen, 72076

  • Universitätsfrauenklinik

    Ulm, 89075

  • Dr. Horst Schmidt Klinik, Gynäkologie u. Gynäkologische Onkologie

    Wiesbaden, 65199

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Lonafarnib
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LonafarnibDrug

    100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day

Study groups in NCT00281515
Study groupRoleWhat they receive
Lonafarnib / Paclitaxel /CarboplatinExperimentalNot described
Receives: Drug: Lonafarnib
Paclitaxel/CarboplatinOtherStandard Chemotherapy
Receives: Drug: Lonafarnib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: every 3 months until PD

Secondary outcomes (6)

  1. Objective tumor response rate (CR/PR (RECIST))

    Measured: During whole trial

  2. Duration of response

    Measured: Until Progression of disease

  3. Overall survival

    Measured: Until date of death

  4. safety based on nature, frequency and severity of adverse events

    Measured: During treatment phase until resolution

  5. Predose lonafarnib concentrations

    Measured: During treatment

  6. PD activity

    Measured: Assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281515
Sponsor's protocol ID
AGO-OVAR 15
Status last verified
Jun 2012
First submitted
24 Jan 2006
Last updated
29 Jun 2012
Results posted
No

Publications

  • 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.

    PubMed 22564713

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lonafarnib in people with Epithelial Ovarian Cancer, run by AGO Study Group at 23 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: every 3 months until PD). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281515, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012.

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