Vectibix for the Treatment of Anal Cancer

NCT01285778 | Completed Phase 2

• 1 other identifier: GEMCAD-0902
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 20

Brief 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

Conditions

Anal Squamous Cell Carcinoma

Keywords

Anal squamous cell carcinoma; panitumumab; chemoradiation; anal cancer; GEMCAD-09-02

Outcome Measures

Primary Outcomes (1)

• Three-year disease-free survival rate

  To estimate the three-year disease-free survival rate in patients treated with 5-FU, mytomicin C and Panitumumab concurrently with radiation therapy as treatment for anal squamous cell carcinoma

  3 years

Secondary Outcomes (7)

• Disease free survival rate

  3 years

• Three-year free local-regional failure rate

  3 years

• Overall survival

  3 years

• Colostomy-free survival rate

  2 years

• Complete response rate

  3 years

Study Arms (1)

Panitumumab, mytomicin C, 5-FU, radiation

EXPERIMENTAL

Drug: panitumumab, mytomicin C, 5-FU, radiation

Interventions

panitumumab, mytomicin C, 5-FU, radiation DRUG

Radiation therapy will be administered concurrent with chemotherapy and Panitumumab treatment. It will start the day 1 of the systemic treatment. That is, the first day of radiation therapy will be the day of the administration of the first dose of Panitumumab and Mitomycin C, as well as the first day of the first 96-hours course of 5-FU continuous infusion. On day 1, drugs and radiation will be administered in the following order: * First, Panitumumab. Panitumumab will be administered by IV infusion on day 1, and every 2 weeks during 8 weeks * Then Mitomycin C, 10mg/m2 on days 1 and 29 * Then start the 5-FU continuous infusion, 1000mg/m2 on days 1-4 and 29-32 * Finally, no less than 2 hours after the start of the 5-FU infusion, first dose of radiation therapy.

Also known as: Vectibix

Panitumumab, mytomicin C, 5-FU, radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Grupo Espanol Multidisciplinario del Cancer Digestivo: lead
• Amgen: collaborator
• Trial Form Support S.L.: collaborator

Study Sites (20)

Hospital Universitario Germans Trias i Pujol. Institut Català Oncologia

Badalona, Barcelona, 08916, Spain

Location

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Centro Oncológico de Galicia

A Coruña, 15009, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario Vall Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial

Barcelona, 08036, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Virgen Blanca

León, 24071, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital General de Valencia

Valencia, 46014, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Panitumumab; Fluorouracil; Radiation

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Physical Phenomena

Study Officials

• Jaime Feliu, MD

  Hospital Universitario La Paz

  STUDY DIRECTOR

• Vicente Alonso, MD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Jaume Capdevila, MD

  Hospital Universitario Vall Hebron

  PRINCIPAL INVESTIGATOR

• Ruth Vera, MD

  Hospital de Navarra

  PRINCIPAL INVESTIGATOR

• Miriam Lopez, MD

  Hospital Infanta Sofia

  PRINCIPAL INVESTIGATOR

• Carmen Castañon, MD

  Hospital Virgen Blanca (León)

  PRINCIPAL INVESTIGATOR

• Carlos Fernández-Martos, MD

  Instituto Valenciano de Oncología

  PRINCIPAL INVESTIGATOR

• Clara Montagut, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Carlos García Girón, MD

  Hospital General Yagüe (Burgos)

  PRINCIPAL INVESTIGATOR

• Ana León, MD

  Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

• Marta Martín, MD

  Hospital de la Santa Creu i Sant Pau de Barcelona

  PRINCIPAL INVESTIGATOR

• Juan Carlos Méndez, MD

  Centro Oncológico de Galicia

  PRINCIPAL INVESTIGATOR

• Rocío García Carbonero, MD

  Hospital Universitario Virgen del Rocío (Sevilla)

  PRINCIPAL INVESTIGATOR

• Jordi Remon, MD

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

• Fernando Rivera, MD

  Hospital Universitario Marqués de Valdecilla (Santander)

  PRINCIPAL INVESTIGATOR

• Laura Cerezo, MD

  Hospital Universitario La Princesa (Madrid)

  PRINCIPAL INVESTIGATOR

• Pilar García-Alfonso, MD

  Hospital Universitario Gregorio Marañón (Madrid)

  PRINCIPAL INVESTIGATOR

• Emilio Fonseca, MD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Aleydis Pisa, MD

  Corporació Sanitaria Parc Taulí (Sabadell, Barcelona)

  PRINCIPAL INVESTIGATOR

• Mónica Caro, MD

  Institut Català d´Oncologia. Hospital Germans Trias i Pujol (Badalona)

  PRINCIPAL INVESTIGATOR

• José María Vicent, MD

  Hospital de Manises, Valencia

  PRINCIPAL INVESTIGATOR

• Isabel Sevilla, MD

  Hospital Universitario Virgen de la Victoria (Málaga)

  PRINCIPAL INVESTIGATOR

• Joan Maurel, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• I Guasch, MD

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

• Jesus Garcia-Foncillas, MD

  Clinica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

• Antonio Arrivi, MD

  Hospital Son Llatzer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 28, 2011
• Study Start: October 1, 2010
• Primary Completion: March 24, 2017
• Study Completion: March 24, 2017
• Last Updated: May 16, 2018

Record last verified: 2018-05

Locations

ES (20)