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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.


Phase 1
18 Years
N/A
Not Enrolling
Female
Cervix Cancer.

Thank you

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

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