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Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Epidermoid Carcinoma, Anus

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Trial Information

Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus


Inclusion Criteria:



- Histologically proven epidermoid carcinoma of the anus

- Locally advanced tumour without metastases

- Stage T2>3 cm or T3 or T4, irrespective of N

- Stage N1-N3 irrespective of T stage (T1 to T4)

- General condition WHO 0-1

- Life expectancy > 3 months

- Signed informed consent form

- Age > 18 years

- Effective contraception in female and/or male patients having reached sexual maturity
during treatment and up to 6 months after the end of treatment

- CD4 > 400 / mm3

- Measureable tumor on at least one of the following exams : MRI, endoscopic
ultrasonography, clinical exam

Exclusion Criteria:

- Presence of metastases

- Previous anti-EGFR therapy

- Stage T1N0 or T2 < 3 cm N0

- History of pelvic radiotherapy

- At least one of the following laboratory test results: Neutrophils < 1500 /mm3,
platelets < 100 000 /mm3, Hb < 9 g/dl, leukocytes < 3000/mm3, blood bilirubin > 1.5
times the upper limit of the normal range, transaminase (ASAT and ALAT) > 2.5 times
the upper limit of the normal range, creatinine clearance < 50 mL/min (Cockcroft's
formula Appendix x), Mg2+ < the lower limit of the normal range, Ca2+ < the lower
limit of the normal range

- Significant coronary artery disease or myocardial infarction in the past year

- Follow-up not possible due to psychological or geographic reasons

- History of interstitial pneumonitis or pulmonary fibrosis

- History of malignant disease in the past five years apart from basocellular skin
carcinoma or in situ cervical carcinoma having received adequate treatment

- Pregnant or breast-feeding women, women of child-bearing potential not having taken a
pregnancy test.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase I = determination the maximum tolerated dose 5FU and panitumumab in combination with radiotherapy and mitomycin, and thereby to deduce the maximum tolerated dose in patient with localised epidermoid carcinoma of the anus

Outcome Description:

Phase I = determine the dose limiting toxicity of 5FU and panitumumab in combination with radiotherapy and mitomycin, and thereby to deduce the maximum tolerated dose in patient with localised epidermoid carcinoma of the anus

Outcome Time Frame:

9 weeks after the beginning of treatment

Safety Issue:

No

Principal Investigator

APARICIO Thomas, MD - PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Avicenne - Bobigny - APHP

Authority:

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

Study ID:

FFCD 0904

NCT ID:

NCT01581840

Start Date:

June 2012

Completion Date:

June 2020

Related Keywords:

  • Epidermoid Carcinoma
  • Anus
  • anus
  • carcinoma
  • panitumumab
  • mitomycine
  • 5Fu
  • radiotherapy
  • Anus Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell

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