Trial Information
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.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer
Principal Investigator
Christophe Hennequin, Physician
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hôpital St Louis, Paris, France
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CACIS
NCT ID:
NCT00251888
Start Date:
November 2002
Completion Date:
November 2005
Related Keywords:
- Cervix Cancer.
- cervix cancer
- advanced cervix cancer
- radiochemotherapy
- pelvic radiotherapy
- campto
- cisplatin
- irinotecan
- cisplatyl
- maximum dose search
- Uterine Cervical Neoplasms