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CompletedNCT00251888Updated Jan 25, 2017

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

A Phase 1 interventional study of campto (irinotecan) and cisplatin (cisplatyl) in Cervix Cancer, sponsored by ARCAGY/ GINECO GROUP. Completed at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by ARCAGY/ GINECO GROUP · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cervix Cancer

Keywords

  • cervix cancer
  • advanced cervix cancer
  • radiochemotherapy
  • pelvic radiotherapy
  • campto
  • cisplatin
  • irinotecan
  • cisplatyl
  • maximum dose search
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

ARCAGY/ GINECO GROUP is the lead sponsor of 51 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants

Interventions

  • Drugcampto (irinotecan)
  • Drugcisplatin (cisplatyl)
06

What researchers measure

Primary outcomes

  1. To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer

Secondary outcomes

  1. To evaluate :

  2. 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

  3. local and general relapse frequency

  4. progression free survival

  5. global survival

07

Study locations

2 sites
  • CRLC Val d'Aurelle
    Montpellier, 34298, France
  • Centre Claudius Régaud
    Toulouse, 31052, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00251888
Lead sponsor
ARCAGY/ GINECO GROUP
First posted
Nov 11, 2005
Start date
Nov 2002
Completion
Nov 2005
Last update
Jan 25, 2017

Study contacts

Christophe Hennequin, Physician
principal investigator · Hôpital St Louis, Paris, France
Nadine Dohollou, physician
principal investigator · Clinique Bordeaux Nord, Bordeaux, France
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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