Clinical trial · Interventional
Study Assessing Potential Predictive Tumor Markers in Metastatic Colorectal Cancer
An Open Label, Phase II Study Assessing Potential Predictive Tumor Markers in Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor Treated With FOLFOX Plus Panitumumab as First-line Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panitumumab + FOLFOX (DP) | Drug | — | UNRESOLVED |
| Panitumumab + FOLFOX (no-DP) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Panitumumab + FOLFOX (DP)
- description
- 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.
- interventionNames
- Drug: Panitumumab + FOLFOX (DP)
- type
- EXPERIMENTAL
- label
- Panitumumab + FOLFOX (no-DP)
- description
- 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.
- interventionNames
- Drug: Panitumumab + FOLFOX (no-DP)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Wild Type K-RAS colorectal cancer determined by the designated Central Laboratory prior to inclusion in the study in the primary tumor and/or at least one metastasis. * 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: 1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with a disease-free interval \> than 6 months after its completion. 2. Recurrence after adjuvant treatment with oxaliplatin +/- radiotherapy with a disease-free interval \> than 12 months 3. 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) Exclusion Criteria: * 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. * Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion * Presence of peripheral neuropathy (Common Toxicity Criteria (CTC) version 3.0 \> grade 1), and of serious nonhealing wound, ulcer, or bone fracture. * Hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion * 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 * Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 14 days prior to inclusion in the study. * Woman or man of childbearing potential not consenting to use adequate contraceptive precautions
References
Publications (1)
- DERIVEDMaurel 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