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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:
ClinicalTrials.gov Identifier:
NCT00251888
First Posted: November 11, 2005
Last Update Posted: January 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ARCAGY/ GINECO GROUP
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00251888     History of Changes
Other Study ID Numbers: CACIS
First Submitted: November 10, 2005
First Posted: November 11, 2005
Last Update Posted: January 25, 2017
Last Verified: February 2011

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
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action