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Taxol Carboplatin and Erythropoetin

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
North Eastern German Society of Gynaecological Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: patients with primary ovarian cancer ECOG- 0-2 Age >= 18 no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥ 100 x 109/l, bilirubin <= 2,0 mg%, creatinine <= 1,5 mg% or creatinine clearance ≥ 60 ml/ min, hemoglobin ≥ 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference laboratory's normal range written informed consent Exclusion Criteria: before-existing heart illness, Cardiac infarct within last 6 months Radiotherapy within 4 weeks for study entry Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Paclitaxel

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%
    Time to progression

    Secondary Outcome Measures

    Toxicity
    defined as hematological and non-hematological adverse events of grade >= grade 1

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    December 12, 2016
    Sponsor
    North Eastern German Society of Gynaecological Oncology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00158379
    Brief Title
    Taxol Carboplatin and Erythropoetin
    Official Title
    Carboplatin With Following Taxol® Therapy Under Additional Application of Epoetin Alfa (ERYPO ®) With Female Patients With Advanced Ovarian Cancer FIGO IA/G3 - IV
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    North Eastern German Society of Gynaecological Oncology

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Time to progression (physical examination and radiologic imaging

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paclitaxel
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Description
    4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
    Primary Outcome Measure Information:
    Title
    Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%
    Description
    Time to progression
    Time Frame
    every 3 months for up to 3 years
    Secondary Outcome Measure Information:
    Title
    Toxicity
    Description
    defined as hematological and non-hematological adverse events of grade >= grade 1
    Time Frame
    after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with primary ovarian cancer ECOG- 0-2 Age >= 18 no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥ 100 x 109/l, bilirubin <= 2,0 mg%, creatinine <= 1,5 mg% or creatinine clearance ≥ 60 ml/ min, hemoglobin ≥ 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference laboratory's normal range written informed consent Exclusion Criteria: before-existing heart illness, Cardiac infarct within last 6 months Radiotherapy within 4 weeks for study entry Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jalid Sehouli
    Organizational Affiliation
    Charite University, Berlin, Germany
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://www.noggo.de
    Description
    Related Info

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    Taxol Carboplatin and Erythropoetin

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