Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2020-01-31

Brief Summary

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* 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

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Detailed Description

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Conditions

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Locally Advanced Cancer in the Anal Region

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cetuximab, Mitomycin C, Fluoruracil

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

Will be given weekly intravenously during study treatment.

Mitomycin C

Intervention Type DRUG

Will be given intravenously twice together with 5-Fluoruracil during study treatment.

5-Fluoruracil

Intervention Type DRUG

Will be given intravenously twice together with Mitomycin C during study treatment

Radiotherapy

Intervention Type RADIATION

Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.

Interventions

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Cetuximab

Will be given weekly intravenously during study treatment.

Intervention Type DRUG

Mitomycin C

Will be given intravenously twice together with 5-Fluoruracil during study treatment.

Intervention Type DRUG

5-Fluoruracil

Will be given intravenously twice together with Mitomycin C during study treatment

Intervention Type DRUG

Radiotherapy

Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No