Vectibix for the Treatment of Anal Cancer

• Status: Completed
• Trial end date: 2017-03-24
• Target enrollment: 0
• Participant gender: All

Summary

Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC. Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical activity in a single report of a refractory anal canal SCC patient. Based on this background, we propose to conduct a phase II study to investigate the efficacy and toxicity of radiotherapy with the association:

• 5-FU 1000mg/m2 on days 1-4 and 29-32

• Mitomycin C 10mg/m2 on days 1 and 29

• Panitumumab 6 mg/kg on day 1, then every 2 weeks for 8 weeks

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo
• Collaborators: Amgen; Trial Form Support S.L.
• Treatments: Antibodies, Monoclonal; Panitumumab

Criteria

Inclusion Criteria:

• Man or woman ≥ 18 years

• Competent to comprehend, sign, and date an IEC-approved informed consent form

• Histologically or cytologically-confirmed anal canal SCC

• T status 2-4 and any N status (pelvic or inguinal) radiologically defined by MRI

• De novo diagnosis of anal canal SCC not previously treated

• ECOG performance status of 0, 1 or 2

• If a subject has prior history of cancer other than anal canal SCC, non-melanoma skin carcinoma, or in situ cervical carcinoma, then the subject should neither have received any treatment nor have shown any signs of active disease within the previous 5 years

• Adequate bone marrow function: neutrophils≥1.5 x109/ L; platelets≥100 x109/ L; hemoglobin≥ 9 g/ dL

• Hepatic function as follows: total bilirubin count ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN

• Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min

• Magnesium≥ lower limit of normal

Exclusion Criteria:

• Metastatic anal canal SCC

• HIV infection (except patients with an undetectable viral load and CD4 cells count >400/mL which are eligible for the study)

• Known hypersensitivity to any of the study drugs

• Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications

• Patients they have received prior systemic therapy or radiotherapy for the treatment of SCC anal carcinoma.

• Prior malignant tumor in the last 5 years, except a history of non-melanoma skin carcinoma, or in situ cervical carcinoma.

• Clinically significant cardiovascular disease, for example myocardial infarction (< 6 months before treatment start), unstable angina, congestive heart failure, arrhythmia requiring medication, or uncontrolled hypertension

• Known positive test for, hepatitis C virus, chronic active hepatitis B infection

• Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures

• Any investigational agent within 30 days before enrolment

• Subject who is pregnant or breast feeding

• Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 28 days prior to inclusion in the study.

• Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods (eg diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last study drug administration for women, and 3 month for men

• Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.