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Taxol Carboplatin and Erythropoetin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00158379
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : November 25, 2016
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
North Eastern German Society of Gynaecological Oncology

Study Description
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Brief Summary:
Time to progression (physical examination and radiologic imaging

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Paclitaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2003
Actual Primary Completion Date : April 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Paclitaxel Drug: Paclitaxel
4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®


Outcome Measures
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Primary Outcome Measures :
  1. 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 Frame: every 3 months for up to 3 years ]
    Time to progression


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years ]
    defined as hematological and non-hematological adverse events of grade >= grade 1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158379


Sponsors and Collaborators
North Eastern German Society of Gynaecological Oncology
Investigators
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Principal Investigator: Jalid Sehouli Charite University, Berlin, Germany
More Information
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Additional Information:

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Responsible Party: North Eastern German Society of Gynaecological Oncology
ClinicalTrials.gov Identifier: NCT00158379    
Other Study ID Numbers: 3002000
First Posted: September 12, 2005    Key Record Dates
Results First Posted: November 25, 2016
Last Update Posted: February 6, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action