Locally Advanced Cancer in the Anal Region Clinical Trial
— NOAC8Official 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
| Verified date | February 2020 |
| Source | Lund University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
- 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
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | January 2020 |
| Est. primary completion date | January 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | University Hospital, Dept. of Oncology | Oslo | |
| Sweden | Skåne University Hospital, Dept. of Oncology | Lund | |
| Sweden | Accademic Hospital, Dept. of Oncology | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Lund University Hospital | Merck Sharp & Dohme Corp. |
Norway, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |