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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00251888

Enrollment

Registered

2005-11-11

Start date

2002-11-30

Completion date

2005-11-30

Last updated

2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix Cancer

Keywords

cervix cancer, advanced cervix cancer, radiochemotherapy, pelvic radiotherapy, campto, cisplatin, irinotecan, cisplatyl, maximum dose search

Brief summary

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

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.

Interventions

DRUGcampto (irinotecan)

DRUGcisplatin (cisplatyl)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer	—

Secondary

Measure	Time frame
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	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026