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Cetuximab

Antineoplastic Agents, Immunological

Patients with metastatic EGFR-positive colorectal carcinoma

Erbitux (Cetuximab)

E-mail: ClinicalTrials@ ImClone.com

This is a phase II, multicenter, target enrollment of 250 evaluable patients, open-label study of cetuximab in patients with refractory, metastatic colorectal carcinoma. Based on prior studies, we predict that 70 to 75% of patients will be EGFR-positive. Patients must have documented failure after receiving either at least two chemotherapy regimens for metastatic disease or adjuvant therapy plus one chemotherapy regimen for metastatic disease provided that the patient progressed within 6 months of completing adjuvant therapy. Prior chemotherapy must have included irinotecan, oxaliplatin, and a fluoropyrimidine.

Patients will receive an initial dose of cetuximab, 400 mg/m2, intravenously (i.v.) over 120 minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who experience unacceptable toxicity or who have progressive disease will not receive further cetuximab therapy.

Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy. Patients with stable disease or a partial or complete response may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a partial or complete response must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.

In addition, there is a pharmacokinetic companion protocol which will determine the trough and peak levels of cetuximab in 25 patients enrolled in the study at four to eight centers. A pharmacologic serum sample for the determination of levels of cetuximab will be obtained prior to the initial, fourth and sixth cetuximab infusions and 1 hour following the completion of the initial, fourth and sixth cetuximab infusions in the first course; and prior to and 1 hour post the completion of the first cetuximab infusion of each subsequent course of therapy. A course of therapy is defined as six weekly infusions of cetuximab monotherapy. ImClone will perform the pharmacokinetic analyses.

Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma

A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma

Eli Lilly and Company

Chief Medical Officer

Disease Progression

Bevacizumab

Irinotecan

Angiogenesis Inhibitors

Growth Inhibitors

Topoisomerase I Inhibitors

Enzyme Inhibitors

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

Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression

Avastin

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

Erbitux

John Souglakos, MD

This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.

Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN

Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

Phase II Study of Avastin Plus Erbitux Plus Irinotecan as 2nd Line Treatment of Locally Advanced or Metastatic Colorectal Cancer in Patients Achieving Disease Progression as Best Response After 1st Line Treatment With FOLFIRI+Avastin or XELIRI+Avastin

University Hospital of Crete

Hellenic Oncology Research Group

In subjects with mCRC, cetuximab will be used in combination with chemotherapy or as a single agent according to the approved national label as in routine clinical practice. Cetuximab 2mg/ml will be administered intravenously via in-line filtration with an infusion pump, gravity drip or a syringe pump. For the initial dose, the recommended infusion period is 120 minutes and for the subsequent weekly doses, the recommended infusion period is 60 minutes.

After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is requested by the Korean Health Authorities to continue monitoring of Erbitux and provide further information about safety and toxicity in clinical practice in at least 900 patients during 6 years.

All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately disclose the EMR 062202-551 study titled "A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509)" on clinicaltrials.gov.

This is a post marketing surveillance (PMS), prospective study to collect safety information from more than 600 subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type metastatic colorectal cancer (mCRC) treated with Erbitux as final evaluable cases. This PMS is requested by the Korean Regulatory Authorities because after removal of an orphan drug in Korea, there is a requirement to investigate more than 600 patients during six years, to continue monitoring and provide further information about safety and toxicity in clinical practice.

This PMS study is planned to be conducted within 6 years from the removal date of orphan drug in approximately 50 institutions in Korea.

OBJECTIVES

The objective of the study is to analyse the safety and efficacy information on the use of Erbitux in the market and factors affecting its safety and efficacy.

Primary objective:

* To obtain safety information on the use of Erbitux in subjects with mCRC in terms of frequency and severity of adverse events (AEs)

Secondary objective:

* To gather clinical efficacy information of the treatment

During the PMS period, each subject's background, medical history (surgery, radiotherapy), Erbitux treatment status, concurrent medication, response evaluation, status and reason of discontinuation, all AEs (regardless of the causal relationship to Erbitux), and abnormal results of laboratory tests will be collected from the start of treatment with Erbitux until progressive disease, Erbitux-related intolerable toxicities, death, or withdrawal of Erbitux treatment (whichever occurs first). The primary endpoint, the safety evaluation will be based on all cases treated with Erbitux having received at least one dose. However, for efficacy evaluation, 12 weeks of treatment have to be applied to each subject.

Erbitux will be prescribed to mCRC subjects according to the approved national label as in routine clinical practice, under the supervision of an investigator experienced in the use of antineoplastic medicinal products. Prior to the first infusion, subjects will receive pre-medication with an antihistamine and a corticosteroid. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered intravenously via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 10 mg/min, equivalent to 5 ml/min of Erbitux 2 mg/ml.

A Korean Post-marketing Surveillance Study on Erbitux® in Patients With Metastatic Colorectal Cancer Refractory to Irinotecan-containing Treatment

A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer

Incidence and severity of all adverse events, regardless of the causal relationship to Erbitux

Best tumour response, time to progression of tumour and duration of response with Erbitux treatment; liver metastasis resectability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma	NCT00044863	Colorectal Neop... Metastases, Neo...	Erbitux (Cetuxi...	18 Years -	Eli Lilly and Company
Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer	NCT00681876	Colorectal Canc...	Irinotecan Avastin Erbitux	18 Years - 72 Years	Hellenic Oncology Research Group
A Korean Post-marketing Surveillance Study on Erbitux® in Patients With Metastatic Colorectal Cancer Refractory to Irinotecan-containing Treatment	NCT01082315	Colorectal Neop...	Erbitux (Cetuxi...	-	Merck KGaA, Darmstadt, Germany

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