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

This study is currently recruiting participants.

Verified by ARCAGY/ GINECO GROUP, August 2007

First Received: August 16, 2007 No Changes Posted

Sponsored by:	ARCAGY/ GINECO GROUP
Information provided by:	ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:	NCT00517621

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms	Drug: Paclitaxel Drug: EPO	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	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

Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:

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

Secondary Outcome Measures:

- 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

Estimated Enrollment:	100
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517621

Contacts

Contact: Esther Plançon, Project mngr

+33 1 42 34 83 23

eplancon@arcagy.org

Locations

France
HOTEL DIEU Hospital	Recruiting
Paris, France
Contact: Laure COPEL, Physician +33 1 44 32 43 49

Sponsors and Collaborators

ARCAGY/ GINECO GROUP

Investigators

Principal Investigator:

Laure COPEL, Physician

Institut CURIE - PARIS

More Information

No publications provided

Study ID Numbers:	ETAMINE
Study First Received:	August 16, 2007
Last Updated:	August 16, 2007
ClinicalTrials.gov Identifier:	NCT00517621 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by ARCAGY/ GINECO GROUP:

Peritoneal cancer
Relapse or progression

Study placed in the following topic categories:

Fallopian Tube Cancer
Neurotoxicity Syndromes
Gonadal Disorders
Disease Progression
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Peritoneal Diseases
Ovarian Cancer
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female

Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female

Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009