A Multicenter Prospective Phase II Study Evaluating Peripheral Neurotoxicity by Using FACT-GOG/NTX Questionnaire in Patients With Ovarian Cancer in Relapse Treated by Paclitaxel +/- EPO. Validation of a French Version of This Questionnaire

ARCAGY/ GINECO GROUP1 site in 1 country100 target enrollmentFebruary 2006

ConditionsOvarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms

DrugsPaclitaxel EPO

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ovarian Cancer
Sponsor: ARCAGY/ GINECO GROUP
Enrollment: 100
Locations: 1
Primary Endpoint: Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with EPO.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

October 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

ARCAGY/ GINECO GROUP

Eligibility Criteria

Inclusion Criteria

•Femal patient aged \> 18 years
•Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneal
•patients whose disease progresses or relapses
•patients having received at least a line of platinum-based chemotherapy
•patients whose treatment of relapse is envisaged to comprise paclitaxel
•patients who will receive EPO for treatment of their anaemia
•ECOG performans status \< 2
•life expectancy \> 16 weeks
•patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria

•peripheral neuropathy grade \> 2
•history of ischemic cardiopathy, congestive heart failure (NYHA\>2), arrhythmia, hypertension or significant valvulopathy
•abnormal biological values
•A therapy or a serious disease which could involve a risk for the patient or interfere with the aims of the study
•patient who is pregnant, breast feeding or using inadequate contraception
•concomitant therapy by a potentially neurotoxic drug
•concomitant inclusion in another therapeutic trial which could interfere with the aims of the study
•patient who for familial, sociological, geographical or psychological condition could not be followed correctly

Outcomes

Primary Outcomes

Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire

Secondary Outcomes

- incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO
- variation of the rate of haemoglobin during chemotherapy
- Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO