Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCAGY/ GINECO GROUP
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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