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NCT Number: NCT00251888

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

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

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Key information

Conditions

Cervix Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

CRLC Val d'Aurelle, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

campto (irinotecan)

Drug

cisplatin (cisplatyl)

Drug

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

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study 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.

Important dates

Study start
2002
Study completion
2005
First posted
Nov 11, 2005
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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