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Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced Cancer in the Anal Region.

Thank you

Trial Information

Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0


Inclusion Criteria:



- Age over 18 years

- Histologically or cytologically confirmed squamous cell cancer of the anal region
(anal canal or anal margin or distal rectum)

- Stage T2 (≥4 cm) - T4 N0-3 M0 or any T N2-3 M0

- ECOG performance status 0-1

- Hb > 100 g/L

- ANC > 1.5 x 10 9/L

- Platelets ≥ 100 x 10 9/L

- Creatinine < 1.5 x ULN

- Bilirubin < 1.5 x ULN

- ALAT < 3.0 x ULN

- Competent to comprehend, sign and date an approved informed consent form

Exclusion Criteria:

- Previous pelvic irradiation

- Previous chemotherapy for anal cancer

- Previous malignancy within the last 5 years, except curatively treated non-melanoma
skin cancer or carcinoma in situ of the cervix uteri

- Pregnant or nursing females or patients of child-bearing potential not using adequate
methods of birth control

- Patients with active infections or any other serious underlying medical condition,
which would impair the ability of the patients to receive the protocol treatment

- Known hypersensitivity to any of the components of the treatment

- Clinically significant cardiovascular disease, e.g. cardiac failure (<12 months
before treatment start), unstable angina, congestive heart failure, arrythmia
requiring medication, or uncontrolled hypertension

- Known positive test for hepatitis C virus, chronic active hepatitis B infection

- Known HIV infection

- Any other condition or therapy which in the investigator´s opinion may pose a risk to
the patient or interfere with the study objectives

- Any investigational agent within 30 days before enrolment

- Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or
radiotherapy within 28 days prior to inclusion in the study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To establish maximum tolerable dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab and radiotherapy in patients with locally advanced cancer in the anal region

Outcome Time Frame:

Participating patients will be followed during the study period; 8 weeks.

Safety Issue:

Yes

Principal Investigator

Anders Johnsson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Skåne University Hospital, Dept. of Oncology

Authority:

Sweden: Medical Products Agency

Study ID:

NOAC8.Version1

NCT ID:

NCT01621217

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Locally Advanced Cancer in the Anal Region.
  • Anal cancer
  • Locally advanced anal cancer
  • Cetuximab
  • 5-fluoruracil
  • Mitomycin C
  • Radiotherapy
  • Anus Neoplasms

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