Study Assessing Potential Predictive Tumor Markers in Metastatic Colorectal Cancer

NCT01288339 | Completed Phase 2

• 2 other identifiers: GEMCAD-09032009-017331-18
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 30

Brief Summary

To estimate the progression free survival for subjects treated with panitumumab in combination with a chemotherapy regimen of oxaliplatin, 5-Fluorouracil (5-FU) and leucovorin (FOLFOX) as first-line chemotherapy regimen for subjects with metastatic colorectal cancer with WT (wild type) KRAS according to the IGFRp (protein receptor insulin growth factor) and MMP-7 (Matrilysin) expression.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival time according to the MMP7 status (PFS)

  To estimate the PFS by DP immunohistochemistry (IHC) expression in patients with wild-type KRAS mCRC treated with panitumumab and mFOLFOX6. Two groups are established by DP status (MMP7+/p-IGF-IR+ vs. MMP7+/p-IGF-IR-, MMP7-/p-IGF-IR+ or MMP7-/p-IGF-IR-).

  5 years

Secondary Outcomes (10)

• Duration of response (DOR)

  5 years

• Time to response (TTR)

  5 years

• Time to treatment failure (TtTF)

  5 years

• Objective response rate (ORR)

  5 years

• Disease Control Rate (DCR)

  5 years

Study Arms (2)

Panitumumab + FOLFOX (DP)

EXPERIMENTAL

Panitumumab and FOLFOX will be administered to patients with DP (MMP7+/p-IGF-IR) once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.

Drug: Panitumumab + FOLFOX (DP)

Panitumumab + FOLFOX (no-DP)

EXPERIMENTAL

Panitumumab and FOLFOX will be administered to patients with no-DP (MMP7+/p-IGF-IR-, MMP7-/p-IGF-IR+ or MMP7-/p-IGF-IR) once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.

Drug: Panitumumab + FOLFOX (no-DP)

Interventions

Panitumumab + FOLFOX (DP) DRUG

Panitumumab and FOLFOX will be administered to patients with DP once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.

Panitumumab + FOLFOX (DP)

Panitumumab + FOLFOX (no-DP) DRUG

Panitumumab and FOLFOX will be administered to patients with no-DP (MMP7+/p-IGF-IR-, MMP7-/p-IGF-IR+ or MMP7-/p-IGF-IR) once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.

Panitumumab + FOLFOX (no-DP)

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 (Ethics Committee) informed consent form
• Histologically-confirmed metastatic adenocarcinoma of the colon or rectum by the investigator.
• At least 1 uni-dimensionally measurable lesion of at least \> 10 mm with spiral CT per modified RECIST criteria 1.1. (Response Evaluation Criteria In Solid Tumors)
• Patients with the following characteristics will be included:
• Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with a disease-free interval \> than 6 months after its completion.
• Recurrence after adjuvant treatment with oxaliplatin +/- radiotherapy with a disease-free interval \> than 12 months
• De novo diagnosis of the disease.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Life expectancy ≥ 3 months
• Adequate bone marrow function
• Adequate Hepatic and metabolic functions
• Adequate Renal function
• Magnesium \> LLN (Lower limit of Normal)

You may not qualify if:

• Patients they have received prior systemic therapy for the treatment of metastatic colorectal carcinoma.
• Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib) or EGFR signal transduction inhibitors.
• Patients who had resection of metastatic disease
• Central nervous system/brain metastases
• Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
• Presence of peripheral neuropathy (Common Toxicity Criteria (CTC) version 3.0 \> grade 1), and of serious nonhealing wound, ulcer, or bone fracture.
• Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
• History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
• Treatment for systemic infection within 14 days before initiating study treatment
• Acute or sub-acute intestinal occlusion and /or active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as \> 4 loose stools per day).
• Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
• Any investigational agent within 30 days before enrollment
• Subject who is pregnant or breast feeding
• Woman or man of childbearing potential not consenting to use adequate contraceptive precautions

Sponsors & Collaborators

• Grupo Espanol Multidisciplinario del Cancer Digestivo: lead
• Amgen: collaborator
• TFS Trial Form Support: collaborator

Study Sites (30)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Son Espases de Mallorca

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Hosptial Son Llatzer de Mallorca

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hosptial General de l'Hospitalet de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08906, Spain

Location

Corporació Sanitaria Parc Taulí de Barcelona

Sabadell, Barcelona, 08208, Spain

Location

Hospital de l'Esperit Sant

Santa Coloma de Gramenet, Barcelona, 08923, Spain

Location

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellon, 12002, Spain

Location

Hosptial de Logroño

Logroño, La Rioja, 26006, Spain

Location

Hospital Universitario La Paz de Madrid

Madrid, Madrdi, 28046, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Xeral Cies de Vigo

Vigo, Pontevedra, 36204, Spain

Location

Centro Oncológico de Galícia

A Coruña, 15009, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau de Barcelona

Barcelona, 08041, Spain

Location

Complejo Asitencia de Burgos. Hospital General Yague

Burgos, 09005, Spain

Location

Hospital General de Ciudad Real

Ciudad Real, 13005, Spain

Location

Institut Català d'Oncologia (ICO) de Girona

Girona, 17007, Spain

Location

Hosptial Dr. Negrin de Las Palmas de Gran Canaria

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Hospital Infanta Sofía de Madrid

Madrid, 28072, Spain

Location

Hospital Universitario Puerta de Hierro de Madrid

Madrid, 28222, Spain

Location

Hospital de Fuenlabrada de Madrid

Madrid, 28942, Spain

Location

Hospital Morales Meseguer

Murcia, 30008, Spain

Location

Hosptial de Sant Pau i Santa Tecla de Tarragona

Tarragona, 43003, Spain

Location

Hospital La Fe de Valencia

Valencia, 46009, Spain

Location

Instituto Valenciano de Oncología de Valencia

Valencia, 46009, Spain

Location

Hospital General de Valencia

Valencia, 46014, Spain

Location

Hospital Dr. Peset de Valencia

Valencia, 46017, Spain

Location

Hospital Miguel Servet de Zaragoza

Zaragoza, 50009, Spain

Location

Related Publications (1)

• Maurel J, Alonso V, Escudero P, Fernandez-Martos C, Salud A, Mendez M, Gallego J, Rodriguez JR, Martin-Richard M, Fernandez-Plana J, Manzano H, Mendez JC, Zanui M, Falco E, Gil-Raga M, Aparicio J, Feliu J, Garcia-Albeniz X, Torres F, Rojo F, Bellosillo B, Mendiola M, Fernandez V, Reig O, Claes B, Maertens G, Sablon E, Jacobs B, Montagut C. Clinical Impact of Circulating Tumor RAS and BRAF Mutation Dynamics in Patients With Metastatic Colorectal Cancer Treated With First-Line Chemotherapy Plus Anti-Epidermal Growth Factor Receptor Therapy. JCO Precis Oncol. 2019 Dec;3:1-16. doi: 10.1200/PO.18.00289.

  PMID: 35100697 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab; Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal 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

Study Officials

• Joan Maurel, MD

  Hospital Clinic i provincial de Barcelona

  STUDY CHAIR

• Marta Martín, MD

  Hospital de la Santa Creu i Sant Pau de Barcelona

  PRINCIPAL INVESTIGATOR

• Antonia Salud, MD

  Hospital Arnau de Vilanova de Lleida

  PRINCIPAL INVESTIGATOR

• Antonio Arrivi, MD

  Hospital Son Llatzer de Mallorca

  PRINCIPAL INVESTIGATOR

• Xavier Hernández, MD

  Intitut Català d' Oncologia (ICO) de Girona

  PRINCIPAL INVESTIGATOR

• Ólbia Serra, MD

  Hospital General de l'Hospitalet de Barcelona

  PRINCIPAL INVESTIGATOR

• Carles Pericay, MD

  Corporació Sanitaria Parc Taulí de Barcelona

  PRINCIPAL INVESTIGATOR

• Isabel Busquier, MD

  Consorcio Hospitalario Provincial de Castellon

  PRINCIPAL INVESTIGATOR

• Carlos Fernandez-Martos, MD

  Instituto Valenciano de Oncología de Valencia

  PRINCIPAL INVESTIGATOR

• Jorge Aparicio, MD

  Hospital Universitario La Fe de Valencia

  PRINCIPAL INVESTIGATOR

• Maria José Safont, MD

  Hospital General Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• Carles Bosch, MD

  Hospital Dr. Peset de Valencia

  PRINCIPAL INVESTIGATOR

• Javier Gallego, MD

  Hosptial General Universitario de Elche

  PRINCIPAL INVESTIGATOR

• Alberto Carmona, MD

  Hosptial Morales Meseguer

  PRINCIPAL INVESTIGATOR

• Jaume Feliu, MD

  Hosptial Universitario La Paz de Madrid

  PRINCIPAL INVESTIGATOR

• Ana Ruíz, MD

  Hospital de Fuenlabrada de Madrid

  PRINCIPAL INVESTIGATOR

• Enrique Casado, MD

  Hospital Infanta Sofía de Madrid

  PRINCIPAL INVESTIGATOR

• Ricardo Cubedo, MD

  Hospital Universitario Puerta de Hierro de Madrid

  PRINCIPAL INVESTIGATOR

• Juana Maria Cano, MD

  Hosptial General de Ciudad Real

  PRINCIPAL INVESTIGATOR

• Vicente Alonso, MD

  Hospital Miguel Servet de Zaragoza

  PRINCIPAL INVESTIGATOR

• Monica Jorge, MD

  Hospital Xeral Cies de Vigo

  PRINCIPAL INVESTIGATOR

• Herminio Manzano, MD

  Hospital Son Dureta de Mallorca

  PRINCIPAL INVESTIGATOR

• Javier Rodríguez, MD

  Clínica Universitaria de Navarra

  PRINCIPAL INVESTIGATOR

• Uriel Bohn, MD

  Hosptial Dr. Negrin de Las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

• Miriam Zorrilla, MD

  Hospital de Logroño

  PRINCIPAL INVESTIGATOR

• Ruth Vera, MD

  Hospital de Navarra

  PRINCIPAL INVESTIGATOR

• Carlos García, MD

  Complejo Asistencial de Burgos. Hospital General Yague

  PRINCIPAL INVESTIGATOR

• Santiago Albiol, MD

  Hospital de l'Esperit Sant de Barcelona

  PRINCIPAL INVESTIGATOR

• José Carlos Méndez, MD

  Centro Oncológico de Galicia (La Coruña)

  PRINCIPAL INVESTIGATOR

• Francisco Javier Ramos, MD

  Hospital de Sant Pau i Santa Tecla de Tarragona

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 24, 2010
• First Posted: February 2, 2011
• Study Start: November 8, 2010
• Primary Completion: February 13, 2015
• Study Completion: February 13, 2015
• Last Updated: May 16, 2018

Record last verified: 2018-05

Locations

ES (30)