Taxol Carboplatin and Erythropoetin

NCT ID: NCT00158379

Last Updated: 2017-02-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2008-06-30

Brief Summary

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Time to progression (physical examination and radiologic imaging

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paclitaxel

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

Interventions

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Paclitaxel

4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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North Eastern German Society of Gynaecological Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jalid Sehouli

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Related Links

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Other Identifiers

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3002000

Identifier Type: -

Identifier Source: org_study_id

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