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Phase 2
18 Years
N/A
Not Enrolling
Female
Cervix Cancer

Thank you

Trial Information


Inclusion Criteria:



- More than 18 years old.

- Epidermoïde carcinoma or adenocarcinoma of the cervix, hystologic proved

- Patientes in a late stage or with progresive desease.

- One mesurable lesion in irradiated zone.

- Patient who have already treated radio-chimiothérapy with platine should have a 6
month free interval.

- Index status of ECOG (" Eastern Cooperative Oncology Group ")less than 2.

- Good biologicals and hematologicals fonctions:

- Neutrophiles noless than 1,5.109/L.

- Platelets nolss than 100.109/L.

- Total bilirubin no more than 1,5 time the normal superior range.

- Transaminases no mote than 3 x Time NSR

- Creatinine clairance Cockroft) more than 50 mL/min .

- Inform consent signed.

Exclusion Criteria:

- Previous cytotoxic traitement exept radio-chaemiotherapy of the pelvis cerebrals
metastasis.

- Other cancer in the last 5 years exept treated BCC.

- Dermatologic desease.

- Crohn desease or Hemorragic rectal-Colitis.

- Neuropathy.

- Psychologic disorder.

- Social troubles.

- Pregnant women.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

responses rate regarding the RECIST criteria.

Outcome Time Frame:

up to progression

Safety Issue:

No

Principal Investigator

Pr KURTZ Jean Emmanuel

Investigator Role:

Principal Investigator

Investigator Affiliation:

STRASBOURG

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ERBUS

NCT ID:

NCT00518193

Start Date:

April 2007

Completion Date:

September 2008

Related Keywords:

  • Cervix Cancer
  • Uterine Cervical Neoplasms

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