Locally Advanced Cancer in the Anal Region
Conditions
Keywords
Anal cancer, Locally advanced anal cancer, Cetuximab, 5-fluoruracil, Mitomycin C, Radiotherapy
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
Interventions
DRUGCetuximab
Will be given weekly intravenously during study treatment.
DRUGMitomycin C
Will be given intravenously twice together with 5-Fluoruracil during study treatment.
DRUG5-Fluoruracil
Will be given intravenously twice together with Mitomycin C during study treatment
RADIATIONRadiotherapy
Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.
Sponsors
Merck Sharp & Dohme LLC
Lund University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Participating patients will be followed during the study period; 8 weeks. |
Countries
Norway, Sweden
Outcome results
None listed