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

Completed

• Conditions: Locally Advanced Cancer in the Anal Region
• Interventions: Drug: Cetuximab; Drug: Mitomycin C; Drug: 5-Fluoruracil; Radiation: Radiotherapy

• Registration Number: NCT01621217
• Lead Sponsor: Lund University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-18
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cetuximab, Mitomycin C, Fluoruracil	5-Fluoruracil	-
Cetuximab, Mitomycin C, Fluoruracil	Radiotherapy	-
Cetuximab, Mitomycin C, Fluoruracil	Cetuximab	-
Cetuximab, Mitomycin C, Fluoruracil	Mitomycin C	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

University Hospital, Dept. of Oncology; 🇳🇴 Oslo, Norway

Skåne University Hospital, Dept. of Oncology; 🇸🇪 Lund, Sweden

Accademic Hospital, Dept. of Oncology; 🇸🇪 Uppsala, Sweden