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Cetuximab Medical Research Studies

Up-to-date List of Cetuximab Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Cetuximab Medical Research Studies

Rank Status Study
1 Recruiting ERBITUX® Followed by Adjuvant Treatment With Chemoradiation and ERBITUX® for Locally Advanced Head and Neck Squamous Cell Carcinoma
Condition: Squamous Cell Carcinoma of the Head and Neck
Interventions: Drug: Cetuximab;   Procedure: Surgery;   Radiation: Post-surgical radiation;   Drug: Cisplatin or carboplatin
Outcome Measures: To determine the extent to which immune biomarkers are modulated in peripheral blood and HNC tumors by preoperative treatment with 4 consecutive weeks of single-agent Cetuximab;   To assess if neoadjuvant modulation of immune and signaling (EGFR pathway blockade) biomarkers can predict antitumor response to adjuvant Cetuximab therapy and clinical outcome.;   To correlate biomarkers with the 2-year progression free survival and disease recurrence of HNC patients treated with surgery, postoperative chemoradiation and adjuvant Cetuximab.;   To determine time to progression and overall survival.
2 Recruiting Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Conditions: Recurrent;   Head and Neck Cancer
Interventions: Radiation: SBRT;   Drug: Cetuximab;   Drug: Docetaxel
Outcome Measures: Locoregional progression-free survival (PFS) of previously-irradiated patients with SCCHN treated with SBRT, Cetuximab, and docetaxel;   Acute and late toxicities associated with the above therapy
3 Recruiting Regorafenib and Cetuximab in Patients With Advanced Malignancy
Condition: Advanced Cancers
Interventions: Drug: Regorafenib;   Drug: Cetuximab;   Behavioral: Questionnaire
Outcome Measure: Maximum Tolerated Dose (MTD) of Treatment with Regorafenib and Cetuximab
4 Recruiting Non-invasive Imaging of Cetuximab-Zr. 89 Uptake Wit PET: a Phase I Trial in Stage IV Cancer Patients
Condition: Stage IV Cancer
Intervention: Drug: Cetuximab-Zr. 89
Outcome Measures: Toxicity (CTCAE 3.0);   Image Quality (Tumour-to-Background Ratio)
5 Recruiting Bevacizumab, Temsirolimus, Valproic Acid, Cetuximab
Condition: Advanced Cancers
Interventions: Drug: Temsirolimus;   Drug: Bevacizumab;   Drug: Valproic Acid;   Drug: Cetuximab
Outcome Measures: Maximum Tolerated Dose (MTD) of Bevacizumab and Temsirolimus and/or Cetuximab or Valproic Acid;   Tumor Response
6 Recruiting Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
Condition: Colorectal Cancer
Interventions: Biological: Imprime PGG + Cetuximab;   Drug: Cetuximab
Outcome Measures: Overall Survival (OS);   Progression Free Survival (PFS);   Rate of complete response (CR);   Rate of partial response (PR);   Rate of overall response (CR + PR);   Safety and tolerability of the dosing regimen as measured by the incidence and severity of adverse events observed in study participants;   Sparse pharmacokinetic profile of Imprime PGG will be determined to expand current Imprime PGG PK data;   Change in Quality of Life
7 Recruiting Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination
Condition: Neoplasms
Interventions: Drug: Regorafenib (Stivarga, BAY73-4506);   Drug: Cetuximab (ERBITUX)
Outcome Measures: Maximum tolerated dose (MTD) of regorafenib in combination with Cetuximab;   Number of participants with Adverse Events as a measure of safety and tolerability;   Cmax (maximum drug concentration in blood) for regorafenib and Cetuximab;   Cmax,md (Cmax after multiple dose) for regorafenib and Cetuximab;   AUC (area under the blood concentration vs time curve from zero to infinity after single (first) dose) for regorafenib and Cetuximab;   AUC(0-24) (AUC from time zero to 24 hours after first-dose administration) for regorafenib;   AUC(0-24)md (AUC from time zero to 24 hours after multiple-dose administration) for regorafenib;   AUC(0-26)md (AUC from time zero to 26 hours after multiple-dose administration) for Cetuximab;   Tumor response according to RECIST 1.1;   tmax (time to reach maximum drug concentration in blood) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and Cetuximab;   tlast (time of last quantifiable drug concentration) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and Cetuximab;   tmax,md (tmax after multiple-dose administration) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and Cetuximab;   tlast,md (tlast after multiple dosing) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and Cetuximab;   AUC(0-tlast) (AUC from time zero to the last data point > lower limit of quantification) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and Cetuximab;   AUC(0-tlast)md (AUC(0-tlast) after multiple dosing) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and Cetuximab;   AUC(0-24)md (AUC from time zero to 24 hours after multiple-dose administration) for regorafenib and its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752);   Cmax for metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752);   Cmax,md for metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752);   AUC(0-1)md (AUC from time zero to 1 hours after multiple-dose administration) for Cetuximab
8 Recruiting A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Conditions: Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC) Patients Who Are Resistant or Ineligible/Intolerant to Platinum-based Chemotherapy.;   Recurrent Head and Neck Squamous Cell Carcinoma;   Metastatic Head and Neck Squamous Cell Carcinoma
Interventions: Drug: BYL719+Cetuximab;   Biological: Cetuximab
Outcome Measures: For Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (Cycle 1=28 days);   For Phase II: Arms 1 and 2: Progression Free Survival (PFS) as per RECIST v1.1;   For Phase II: Arm 3: Progression Free Survival (PFS) as per RECIST V1.1;   For Phase Ib: Number of patients with Adverse Events (AEs);   For Phase Ib: Plasma concentration vs. time profiles, plasma pharmacokinetics (PK) parameters of BYL719;   For Phase Ib: Overall Response Rate (ORR) as per RECIST v1.1;   For Phase Ib: Disease Control Rate (DCR) as per RECIST v1.1;   For Phase Ib: PFS as per RECIST v1.1;   For Phase II: ORR as per RECIST v1.1;   For Phase II: DCR as per RECIST v1.1;   For Phase II: Overall Survival (OS) from the date of randomization;   PFS as per RECIST v 1.1;   For Phase Ib: Dose interruptions, reductions and dose intensity;   For Phase Ib: Number of patients with Serious AEs (SAEs);   For Phase Ib: Changes in laboratory values (hematology and chemistry values), vital signs, electrocardiograms (ECGs);   For Phase II: Dose interruptions, reductions and dose intensity;   For Phase II: Number of patients with Adverse Events (AEs);   For Phase II: Plasma concentration vs. time profiles, plasma pharmacokinetics (PK) parameters of BYL719;   For Phase II: Changes in laboratory values (hematology and chemistry values), vital signs, electrocardiograms (ECGs);   For Phase II: Number of patients with Serious AEs (SAEs);   Phase II, Scheme 2 (Arm 2B): OS from the time of crossing over;   Phase II, Scheme 1 (arm 2B): ORR;   Phase II, Scheme 1 (Arm 2B): DCR as per RECIST v1.1.;   Phase II, Scheme 2: (Arm 3): ORR;   Phase II, Scheme 2: (Arm 3): DCR as per RECIST v1.1;   Phase II, Scheme 2 (Arm 3): Overall Survival (OS)
9 Recruiting Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed By Surgery
Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma;   Recurrent Metastatic Squamous Neck Cancer With Occult Primary;   Recurrent Salivary Gland Cancer;   Recurrent Squamous Cell Carcinoma of the Hypopharynx;   Recurrent Squamous Cell Carcinoma of the Larynx;   Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity;   Recurrent Squamous Cell Carcinoma of the Nasopharynx;   Recurrent Squamous Cell Carcinoma of the Oropharynx;   Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity;   Recurrent Verrucous Carcinoma of the Larynx;   Recurrent Verrucous Carcinoma of the Oral Cavity;   Salivary Gland Squamous Cell Carcinoma;   Stage III Salivary Gland Cancer;   Stage III Squamous Cell Carcinoma of the Hypopharynx;   Stage III Squamous Cell Carcinoma of the Larynx;   Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage III Squamous Cell Carcinoma of the Nasopharynx;   Stage III Squamous Cell Carcinoma of the Oropharynx;   Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity;   Stage III Verrucous Carcinoma of the Larynx;   Stage III Verrucous Carcinoma of the Oral Cavity;   Stage IV Squamous Cell Carcinoma of the Hypopharynx;   Stage IV Squamous Cell Carcinoma of the Nasopharynx;   Stage IVA Salivary Gland Cancer;   Stage IVA Squamous Cell Carcinoma of the Larynx;   Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage IVA Squamous Cell Carcinoma of the Oropharynx;   Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity;   Stage IVA Verrucous Carcinoma of the Larynx;   Stage IVA Verrucous Carcinoma of the Oral Cavity;   Stage IVB Salivary Gland Cancer;   Stage IVB Squamous Cell Carcinoma of the Larynx;   Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage IVB Squamous Cell Carcinoma of the Oropharynx;   Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity;   Stage IVB Verrucous Carcinoma of the Larynx;   Stage IVB Verrucous Carcinoma of the Oral Cavity;   Stage IVC Salivary Gland Cancer;   Stage IVC Squamous Cell Carcinoma of the Larynx;   Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage IVC Squamous Cell Carcinoma of the Oropharynx;   Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity;   Stage IVC Verrucous Carcinoma of the Larynx;   Stage IVC Verrucous Carcinoma of the Oral Cavity;   Tongue Cancer;   Untreated Metastatic Squamous Neck Cancer With Occult Primary
Interventions: Drug: tivantinib;   Biological: Cetuximab;   Other: laboratory biomarker analysis
Outcome Measures: Response rate assessed according to RECIST;   Change in tumor burden, measured using the sum of longest diameters of target lesion;   PFS;   OS;   Change in c-MET expression;   Change in c-MET copy number;   Activity of single-agent tivantinib after failure of Cetuximab
10 Recruiting Dual Targeting of EGFR With Cetuximab and Afatinib to Treat Refractory wtKRAS Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
Interventions: Drug: Cetuximab + Afatinib;   Drug: Cetuximab
Outcome Measures: Non progression rate at 6 months;   Overall response rate (OR);   Progression free survival;   Overall and specific survival;   Quality of life;   Tolerance of the treatment
11 Recruiting Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma
Conditions: Thymoma;   Thymic Carcinoma.;   Clinical Masaoka Stage II-IVA
Intervention: Drug: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
Outcome Measures: To determine the frequency of complete pathologic response to neo-adjuvant therapy with cisplatin, doxorubicin, cyclophosphamide (CAP) and Cetuximab in patients with clinical Masaoka stage II-IVa thymoma and thymic carcinomas.;   To determine the toxicity (CTCAE v.3) of neo-adjuvant therapy with CAP and Cetuximab;   To measure the radiographic response rate to Cetuximab alone after 4 weeks;   To determine the radiographic response rate to CAP and Cetuximab;   To determine the complete resection rate (R0) after neo-adjuvant therapy with CAP and Cetuximab;   To correlate percentage of pathologic response to unidimensional and volumetric radiographic response
12 Not yet recruiting Image Guided Treatment Optimization With Cetuximab for Patients With Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
Interventions: Drug: Dose escalation Cetuximab;   Drug: Standard dose Cetuximab
Outcome Measures: Uptake (SUV) of 89Zr-Cetuximab in extra-hepatic metastases on PET-scan;   Clinical Benefit Rate;   Early response evaluation with 18F-FDG PET;   Tumor perfusion as early response evaluation (measured with 15O-H2O-PET);   Overall survival;   Progression Free Survival;   Skin toxicity and hypomagnesemia as early response marker;   Quality of life (QoL) and health related QoL
13 Recruiting Randomised Phase II, Cetuximab in Combination With 5FU and Cisplatin or Carboplatin Versus Cetuximab in Combination With Paclitaxel and Carboplatin for Treatment of Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Squamous Cell Carcinoma of the Head and Neck
Intervention: Drug: Cetuximab
Outcome Measures: Progression free survival;   Best overall response
14 Recruiting Radiotherapy With Cisplatin vs. Docetaxel-Cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Condition: Squamous Cell Carcinoma of the Oropharynx, Larynx, or Hypopharynx
Interventions: Drug: Cisplatin;   Radiation: IMRT;   Drug: Docetaxel;   Drug: Cetuximab
Outcome Measures: Evaluate the efficacy of radiotherapy with concurrent docetaxel-Cetuximab vs. cisplatin in patients with locally advanced HNSCC and increased tumoral ERCC1 expression, as measured by time to progression (TTP);   Evaluate the efficacy of radiotherapy with concurrent docetaxel-Cetuximab vs. cisplatin in patients with PULA HNSCC and decreased/normal tumoral ERCC1 expression, as measured by TTP;   Evaluate the efficacy of radiotherapy with concurrent docetaxel-Cetuximab vs. cisplatin in all patients irrespective of ERCC1 status, as measured by TTP;   Prospectively validate the candidate cutpoint for decreased/normal vs. increased ERCC1 [4F9] expression in patients treated with cisplatin-IMRT;   Prospectively investigate two sets of radiologic interpretive criteria, including RECIST 1.1 and integrated PET/CT, for the designation of complete response (CR), and to compare the ability of the two CR classifications to accurately predict 2-year TTP.
15 Recruiting Cetuximab Standard or Dose Escalation in First Line Colorectal Cancer
Condition: Colorectal Cancer
Interventions: Drug: Dose escalation of Cetuximab;   Drug: Standard first line treatment with Cetuximab + Folfiri
Outcome Measures: PFS rate at 9 months in the dose escalation arm;   Safety profile (NCI-CTCAE v. 4.0) of the combination in treatment arms;   Skin toxicity and correlations between outcome, PK and dose escalations;   Overall response and response rate in liver-limited disease;   Disease control rates;   Duration of response;   Progression free survival and overall survival;   R0 resection rate for metastatic lesions;   Pharmacokinetic parameters in patients in both treatment arms in selected centers only;   To perform biomarker analyses: proteomics, microarray and PCR studies on plasma and tumour respectively, in both treatment arms.
16 Not yet recruiting Efficacy and Safety of Cetuximab in Metastatic Penile Carcinoma (PENILANE)
Condition: Squamous Cell Carcinoma of the Penis
Interventions: Drug: Cetuximab;   Drug: TIP
Outcome Measures: Evaluation of the antitumor activity of Cetuximab treatment in terms of Objective Response Rate (ORR) at the end of treatment;   Evaluation of the Safety Profile of Cetuximab treatment;   Evaluation of the antitumor activity of Cetuximab treatment in terms of Overall Survival (OS) at the end of the study;   Evaluation of the antitumor activity of Cetuximab treatment in terms of Progression-Free Survival (PFS) at the end of the study;   Evaluation of Quality of Life during the Cetuximab treatment
17 Recruiting Treatment Optimization of Cetuximab in Patients With Metastatic Colorectal Cancer Based on Tumor Uptake of 89Zr-labeled Cetuximab Assessed by PET
Condition: Colorectal Cancer
Intervention: Behavioral: pharmacodynamic purposes of 89Zr-labelled Cetuximab and kinase activity profiles
Outcome Measures: The detection of 89Zr-Cetuximab uptake in non-hepatic tumor lesions;   The % uptake (of total injected) 89Zr-Cetuximab in non-hepatic tumor lesions;   The % uptake (of total injected) 89Zr-Cetuximab in liver lesions;   [18F-]FDG PET measurements;   Grade of skin toxicity
18 Recruiting Paclitaxel, Carboplatin and Cetuximab (PCC) Versus Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Condition: Head and Neck Squamous Cell Carcinoma
Interventions: Drug: Paclitaxel;   Drug: Carboplatin;   Drug: Cetuximab;   Drug: Docetaxel;   Drug: Cisplatin;   Drug: Fluorouracil;   Radiation: Radiotherapy (RT);   Other: Chemotherapy
Outcome Measure: Number of Patients with Progression-free survival (PFS)
19 Recruiting Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN
Conditions: Squamous Cell Carcinoma of the Hypopharynx Stage III;   Squamous Cell Carcinoma of the Hypopharynx Stage IV;   Squamous Cell Carcinoma of the Larynx Stage III;   Squamous Cell Carcinoma of the Larynx Stage IV;   Squamous Cell Carcinoma of the Oropharynx Stage III;   Squamous Cell Carcinoma of the Oropharynx Stage IV;   Squamous Cell Carcinoma of the Oral Cavity Stage III;   Squamous Cell Carcinoma of the Oral Cavity Stage IV
Interventions: Drug: Docetaxel;   Drug: Cisplatin;   Drug: 5-fluorouracil;   Biological: Cetuximab Induction;   Biological: Cetuximab Radioimmunotherapy;   Radiation: Boost irradiation
Outcome Measures: Response Rate (CR, PR);   Overall Response Rate (CR, PR, PD, SD);   Locoregionally monitoring;   Progression Free Survival (PFS);   Toxicity;   Overall-Survival
20 Recruiting Cetuximab for Elderly Patients With mCRC
Condition: Metastatic Colorectal Cancer
Interventions: Drug: Cetuximab;   Drug: Capecitabine
Outcome Measures: Progression free survival in week 12;   Quality of life (QL);   Adverse events (CTCAE v 4.0);   Overall Response (OR);   Progression free survival (PFS);   Overall Survival (OS);   Overall treatment utility (OTU) (predefined composite endpoint including clinical benefit, tolerability and acceptability of the treatment)

These studies may lead to new treatments and are adding insight into Cetuximab etiology and treatment.

A major focus of Cetuximab research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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