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CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto

This study has been completed.
Sponsor:
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00251888
First received: November 10, 2005
Last updated: February 24, 2011
Last verified: February 2011
History of Changes
  Purpose

Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.


Condition Intervention Phase
Cervix Cancer.
 Drug: campto (irinotecan)
Drug: cisplatin (cisplatyl)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Etude de Recherche de Dose de l'Association Irinotecan (Campto(R)) - Cisplatine (Cisplatyl(R)) Avec la radiothérapie Pelvienne Dans Les Cancers avancés du Col de l'utérus.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer

Secondary Outcome Measures:
  • To evaluate :
  • the global response rate judged on standard clinical criteria, echography, tomodensiometry, and MRI. The histologic response rate will be appreciated in patients who had a second surgery after pelvic radiochemotherapy
  • local and general relapse frequency
  • progression free survival
  • global survival

Estimated Enrollment: 15
Study Start Date: November 2002
Study Completion Date: November 2005
Detailed Description:

To determine the maximum and the recommended tolerated dose of irinotecan with increasing doses associated with weekly cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer, IIB-IVA FIGO stage.

  Eligibility

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

Inclusion Criteria:

  • Histologically proven primitive epidermoid or andenocarcinoma Cervix
  • FIGO stage IIB (obviously parameter attack), III or IVA
  • No previous chemotherapy nor radiotherapy
  • Patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma
  • PS ECOG < 2
  • Life expectancy > 12 weeks
  • Written consent given

Exclusion Criteria:

  • Other malignant cervix tumor histology
  • Visceral remotly metastasis
  • Other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer
  • Anormal labs values
  • Peripheric neuropathy CTC > 2
  • Auditory loss > 2
  • Cardiopathy
  • Inflammatory digestive pathology
  • Evolutive infection
  • Other experimental concommitant treatment
  • Lacting or pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251888

Locations
France
CRLC Val d'Aurelle
Montpellier, France, 34298
Centre Claudius Régaud
Toulouse, France, 31052
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Christophe Hennequin, Physician Hôpital St Louis, Paris, France
Principal Investigator: Nadine Dohollou, physician Clinique Bordeaux Nord, Bordeaux, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00251888     History of Changes
Other Study ID Numbers: CACIS
Study First Received: November 10, 2005
Last Updated: February 24, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ARCAGY/ GINECO GROUP:
cervix cancer
advanced cervix cancer
radiochemotherapy
pelvic radiotherapy
campto
 cisplatin
irinotecan
cisplatyl
maximum dose search

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Irinotecan
Cisplatin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013