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

ARCAGY/ GINECO GROUP

Status and phase

Completed

Phase 1

Conditions

Cervix Cancer

Treatments

Drug: cisplatin (cisplatyl)

Drug: campto (irinotecan)

Study type

Interventional

Funder types

Other

Identifiers

NCT00251888

CACIS

Details and patient eligibility

About

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

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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