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

Cervix Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251888
• Other study ID #: CACIS
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2005
• Last updated: January 24, 2017
• Start date: November 2002
• Est. completion date: November 2005

Study information

• Verified date: February 2011
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• campto (irinotecan)

• cisplatin (cisplatyl)

Locations

Country	Name	City	State
France	CRLC Val d'Aurelle	Montpellier
France	Centre Claudius Régaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer
Secondary	To evaluate :
Secondary	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
Secondary	local and general relapse frequency
Secondary	progression free survival
Secondary	global survival