Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Digestive System Diseases

Exanthema

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Coagulants

Vitamins

Irinotecan

Antibodies

Antibodies, Monoclonal

Cetuximab

Fluorouracil

Folic Acid

Immunoglobulins

Mitogens

Vitamin B Complex

Vitamin K

Vitamin K 1

Antineoplastic Agents, Immunological

Folinic Acid

Menadione

Menaquinone

Naphthoquinone

Phylloquinone

Folate

Vitamin B9

1. Cetuximab (Erbitux® )- Cetuximab is a recombinant IgG1 chimeric monoclonal antibody directed against human epidermal growth factor receptor (EGFR).
2. FOLFIRI regimen

Administration Schedule:

Cetuximab at a initial dose 400 mg/sqm (first week), then 250 mg/sqm on day 1 and 8 Background Chemotherapy (every two weeks)

* Irinotecan 180 mg/m² iv , 90 min on day 1
* Folic acid (racemic) 400 mg/m², 120 min on day 1
* 5-FU 400 mg/m² bolus on day 1
* 5-FU 2400 mg/m² iv over 46 h on day 1 to 2

FOLFIRI + Cetuximab

Carl Christoph Schimanski, PD Dr. med.

The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis.

Further Objectives:

1. Development of acneiforme follicular exanthema \>= grade 2
2. Duration until development of acneiforme follicular exanthema \>= grade 2
3. Development of paronychia
4. Development skin fissure (hand and foot)
5. Objective remission according RECIST 1.1
6. Rate of secondary resections of liver metastasis with a curative approach
7. Assessment of safety and tolerability
8. Overall survival
9. Progression free survival

Subjects with metastatic colorectal cancer and confirmed KRAS-wildtype status in 1st line therapy will be included in this phase IV-study. Subject will receive a regimen of FOLFIRI in combination with Cetuximab every two weeks during study treatment phase. Treatment continues until

* disease progression
* complete response
* development of status of operability
* an uncontrollable exanthema grade 3 or 4 or
* intolerable toxicity is diagnosed. After study discontinuation or end of treatment, respectively, patients will be followed up until the the last patient was treated for 12 months and has completed the 36-months follow up phase. Tumor response will be evaluated (according to RECIST 1.1) every 12 weeks and at the end of study treatment

FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

Non-randomized Phase-IV-study to Investigate the Efficacy of FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

Progression-free survival rate at 12 months

Objective response rate over the entire treatment period

Duration until development of acneiforme follicular exanthema \>= grade 2 during treatment-phase

Development of paronychia during treatment-phase

Development of skin fissure (hand and foot) during treatment-phase

Rate of secondary resections of metastasis of liver with a curative approach during treatment-phase

Assessment of safety and tolerability during treatment phase

Development of acneiforme follicular exanthema \>= grade2 during treatment phase

Dr. Carl Schimanski

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Carboplatin

Pemetrexed

Cisplatin

Patients will be treated with standard chemotherapy (4-6 cycles), combined with weekly administration of Cetuximab (Erbitux) until disease progression.

Cetuximab (Erbitux)

Veerle Surmont, MD

Multicenter, open phase 2 study on patients with malignant mesothelioma. Standardly, 4 to 6 cycles of palliative chemotherapy, platinum in combination with pemetrexed, are given. Despite of this treatment, median survival is poor (9-12 months). By combining conventional cytotoxic agents with a novel agent, hopefully treatment and survival can be approved. Cetuximab or Erbitux is a monoclonal antibody against the EGFR (Epidermal Growth Factor Receptor). By blocking the receptor, it interferes with cel growth and division. Most mesothelioma show a strong expression of the EGFR protein. Apart from that, Cetuximab also has antibody-dependent cell-mediated cytotoxicity (ADCC).

In this trial, patients will be treated with standard chemotherapy, combined with Cetuximab weekly. After a maximum of 6 cycles of chemotherapy, administration of Cetuximab will be continued until disease progression. Every 6 weeks, a CT scan will be done to evaluate therapy. Most common side effect of Cetuximab is acneiform rash.

The translation research program consists of the determination of EGFR- and K-Ras mutations on the tumor tissue and the correlation with outcome.

In the first part of the trial, 18 patients will be included. After a positive interim analysis, a total of 43 patients will be included.

A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.

Phase II Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.

Merck Sharp & Dohme LLC

University Hospital, Ghent

Oxaliplatin

Bevacizumab

Capecitabine

Antimetabolites

Topoisomerase I Inhibitors

Enzyme Inhibitors

Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression

Capecitabine (p.o) 2000 mg/m2 (1000 mg/m2 x 2) on day 1-7 every 2 weeks until progression

Cetuximab(IV) 500 mg/m2 on day 1 every two weeks until progression

Oxaliplatin (I.V) 85 mg/m2 on day 1 every two weeks until progression

John Souglakos, MD

This phase II study will evaluate which is the best way to administer cetuximab after recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment.

Because of the recent advances in the field of systemic chemotherapy for mCRC, like irinotecan, oxaliplatin, capecitabine, and targeted agents (Cetuximab, Bevacizumab) mCRC patients have an overall survival that in some cases reaches 25 months.Irinotecan is an inhibitor of the DNA enzyme topoisomerase I, with use in clinical practice for the last 10 years.In a phase II study with mCRC patients resistant to irinotecan based therapy the combination of irinotecan and Cetuximab (an IgG1 anti-EGFR antibody) yielded a response rate of 22.5%.Capecitabine was shown to have improved tolerability and response rate compared with bolus 5-FU, with comparable time to progression and survival.Oxaliplatin has been approved by the FDA for 2nd line treatment in the metastatic CRC setting as a number of trials have shown promising data for response rates, disease stabilization rates,median progression free survival (PFS) and overall survival (OS).KRAS is a predictive marker for clinical benefit from EGFR-based antibody treatment. KRAS is the first molecular marker for selection of a targeted therapy in combination with a standard chemotherapy regimen. Patients with KRAS wild-type tumors have a strong benefit from the administration of cetuximab with better PFS and objective responses.

Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC

A Parallel Phase II Study With Irinotecan/Cetuximab (Until PD) Followed by XELOX/Cetuximab (Until PD) vs the Reverse Sequence in Metastatic CRC With Previous Benefit on Irinotecan/Bevacizumab Based Therapy

University Hospital of Crete

Hellenic Oncology Research Group

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8

Cetuximab,injection,loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8)

cetuximab (Erbitux)

Paclitaxel,injection,loading dose 45 mg/m\^2,(Day1 in every week for Weeks 2-8)

Cisplatin,injection,loading dose 20 mg/m\^2,(Day1 in every week for Weeks 2-8)

Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).

Radiation

Jin Ming Yu, PH.D, M.D

The purpose of this study is to determine whether the treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation improve clinical outcomes.

Esophageal cancer is the sixth leading cause of cancer death worldwide.

Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting.

Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer.

Accumulating clinical evidence suggests that epidermal growth factor receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Cetuximab, a monoclonal antibody, binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor (TGF)-α.

Preclinical models have suggested synergy between cetuximab, paclitaxel, cisplatin and radiation. For patients with locally advanced head and neck cancer, the combination of cetuximab and radiation has demonstrated both response and survival benefit.

With all these, the investigators hypothesize that treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation may further improve clinical outcomes. This trial results will be important as it may support further studies for setting the new treatment standard for ESCC.

Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma

An Open-labeled Study to Evaluate Efficacy of Combining Erbitux Plus Concurrent Chemo-radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)

The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3-6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

All patients were regularly monitored for possible adverse events, which were graded according to National Cancer Institute Common Toxicity Criteria version 3.0.

DNA was extracted from tumor specimens.Screened for the presence of KRAS codon 12 and 13 mutations using a PCR clamping and melting curve technique. PCR amplification of the wild-type KRAS sequence was suppressed in this process by the incorporation in the reaction mix of a locked nucleic-acid oligomer16 spanning codons 12 and 13 of the KRAS gene. Post-PCR hybridization and melting curve analysis using fluorescently tagged oligonucleotides incorporated in the original PCR reaction permitted the identification and discrimination of distinct KRAS codon 12 and 13 missense mutations.

Chinese Academy of Medical Sciences

Peking University Cancer Hospital & Institute

Hebei Fourth Hospital

Jiangsu Cancer Institute & Hospital

RenJi Hospital

The Affiliated Cancer Hospital of Zhengzhou University

West China Hospital

Shandong Cancer Hospital and Institute

Jinming Yu

Cetuximab, Concurrent Chemo-radiotherapy

Age, Categorical

Age Continuous

Sex: Female, Male

China

Region of Enrollment

Number of Participants With Overall Response Rate (RR)

Number of Participants With Toxicity

Participants With Overall Survival (OS) at 1 Year

Participants With Overall Survival (OS) at 3 Year

Participants With Progression Free Survival (PFS)

Number of Participants With K-ras Gene Mutation

Overall Study

Leucovorin

Levoleucovorin

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

500 mg/m² every second week, intravenous infusion, 8 cycles

Given in combination day 1 and 2, every second week, 8 cycles

Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid

Per Pfeiffer, MD

The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or C). Effect-data has not yet been published but the combination is well tolerated, and other studies have shown that Erbitux administered with chemotherapy seem to be more efficient than chemotherapy alone.

The main purpose with this study is to investigate the effect of FLOX and Erbitux given every second week as first line treatment for patients with metastatic colorectal cancer and K-RAS wildtype tumor.

The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations.

FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor

FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study

Odense University Hospital

Per Pfeiffer

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema	NCT01315990	Colorectal Canc...	FOLFIRI + Cetux...	18 Years -	Johannes Gutenberg University Mainz
A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.	NCT00996567	Cancer	Cetuximab (Erbi...	18 Years -	University Hospital, Ghent
Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC	NCT00755534	Colorectal Canc...	Irinotecan Capecitabine Cetuximab Oxaliplatin	18 Years - 72 Years	Hellenic Oncology Research Group
A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.	NCT00996567	Cancer	Cetuximab (Erbi...	18 Years -	University Hospital, Ghent
Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma	NCT00815308	Esophageal Canc...	cetuximab (Erbi... Paclitaxel Cisplatin Radiation	18 Years - 70 Years	Shandong Cancer Hospital and Institute
Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma	NCT00815308	Esophageal Canc...	cetuximab (Erbi... Paclitaxel Cisplatin Radiation	18 Years - 70 Years	Shandong Cancer Hospital and Institute
A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.	NCT00996567	Cancer	Cetuximab (Erbi...	18 Years -	University Hospital, Ghent
FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor	NCT00660582	Metastatic Colo...	Cetuximab (Erbi... Oxaliplatin (El...	18 Years - 75 Years	Odense University Hospital
FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema	NCT01315990	Colorectal Canc...	FOLFIRI + Cetux...	18 Years -	Johannes Gutenberg University Mainz
Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma	NCT00815308	Esophageal Canc...	cetuximab (Erbi... Paclitaxel Cisplatin Radiation	18 Years - 70 Years	Shandong Cancer Hospital and Institute

Spots Global Cancer Trial Database for cetuximab (erbitux)