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

NCT00517621 | Completed Phase 2

• 1 other identifier: ETAMINE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Neoplasms

Keywords

Peritoneal cancer; Relapse or progression

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• - 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

Interventions

Paclitaxel DRUG

EPO DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• patient who for familial, sociological, geographical or psychological condition could not be followed correctly

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead

Study Sites (1)

HOTEL DIEU Hospital

Paris, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Recurrence; Disease Progression

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Laure COPEL, Physician

  Institut Curie Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: February 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 25, 2011

Record last verified: 2011-02

Locations

FR (1)