Clinical trial NCT01621217: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Locally Advanced Cancer in the Anal Region
Keywords: Anal cancer
Locally advanced anal cancer
Cetuximab
5-fluoruracil
Mitomycin C
Radiotherapy
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-06-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab in patients with locally advanced cancer in the anal region
* To evaluate acute toxicity
* To evaluate late toxicity
* To evaluate response rate
* To evaluate recurrence free survival
* To evaluate overall survival


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Participating patients will be followed during the study period; 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University Hospital, Dept. of Oncology
city: Lund
country: Sweden
facility: Skåne University Hospital, Dept. of Oncology
city: Uppsala
country: Sweden
facility: Accademic Hospital, Dept. of Oncology
Study officials:
affiliation: Skåne University Hospital, Dept. of Oncology
name: Anders Johnsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leon O, Guren MG, Radu C, Gunnlaugsson A, Johnsson A. Phase I study of cetuximab in combination with 5-fluorouracil, mitomycin C and radiotherapy in patients with locally advanced anal cancer. Eur J Cancer. 2015 Dec;51(18):2740-6. doi: 10.1016/j.ejca.2015.08.029. Epub 2015 Nov 18.