Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Irinotecan

Cetuximab

Chlorotrianisene

Liver Extracts

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Irinotecan drug-eluting beads administered by hepatic chemoembolization with intravenous cetuximab (DEBIRITUX)

systemic treatment with intravenous cetuximab and irinotecan

Starting dose of 400mg/m2, followed by weekly 250mg/m2

Irinotecan 180 mg/m² to be administered every two weeks

A minimum of two treatments per lobe (four bi-weekly sessions in the event of bilobar disease) at week 0 and 4 with up to 4ml (100-300µm DC Bead loaded with up to 200mg irinotecan) will be scheduled (i.e. for bilobar disease right lobe: week 0, left lobe: week 2, right lobe: week 4 and left lobe: week 6: following toxicity and extending interval if toxicity seen).

Irinotecan eluting BEADS

Dirk Arnold, MD

The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in combination with intravenous cetuximab versus intravenous irinotecan in combination with intravenous cetuximab in the treatment of patients with unresectable liver metastases from colorectal cancer.

Secondary objectives are safety and tolerability of hepatic chemoembolization and the question if the addition of aprepitant to standard antiemetic prophylaxis in patients treated by hepatic chemoembolization is safe and will reduce the rate of acute and delayed nausea and emesis.

About half of patients with newly diagnosed colorectal cancer will develop metastatic disease and, however, in spite of the significant progress in the therapeutical strategies for metastatic disease, virtually all patients will eventually succumb to their illness. Based on prior clinical data there is a good rationale for the expectation that the combination of systemic chemotherapy and arterial chemoembolization with drug eluting beads may be effective in the setting of patients with unresectable or chemorefractory liver metastases. The aim of this study is therefore to assess whether the combination of Irinotecan eluting beads and intravenous cetuximab is safe and effective in the treatment of patients with unresectable liver metastases from refractory colorectal cancer and will result in a prolongation of disease control when compared to standard systemic treatment with intravenous irinotecan and intravenous cetuximab. In this patient group, intravenous irinotecan plus intravenous cetuximab may represent the "standard of care", with a previously described activity. The patient group is defined in terms of pretreatment, and the scientific question is whether the way of irinotecan administration by eluting beads in feasible and somehow beneficial.

TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal Cancer

A Randomized Phase II Trial of Irinotecan Drug-eluting Beads Administered by Hepatic Chemoembolization With Intravenous Cetuximab (DEBIRITUX) Versus Systemic Treatment With Intravenous Cetuximab and Irinotecan in Patients With Refractory Metastatic Colorectal Cancer and K-ras Wild-type Tumours

extent of necrosis in the treated lesions

Biocompatibles UK Ltd

Hans-Joachim Schmoll, MD

Trametinib

Panitumumab

Protein Kinase Inhibitors

Trametinib: 2 mg QD, orally, continuously.

Panitumumab: 6 mg/kg, intravenously, Q2W

Philippe Bedard, M.D.

This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful the combination of two drugs, panitumumab and trametinib, are in patients with advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).

Panitumumab is a drug that is approved by Health Canada for the treatment of advanced colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the protein, epidermal growth factor receptor (EGFR) from working.

Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working.

Previous studies have shown that the combination of panitumumab and trametinib may be more useful in KRAS, NRAS, or BRAF wild type colorectal cancer.

A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer

Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies

University Health Network, Toronto

Liver Neoplasms

Neoplastic Processes

Liver Diseases

Micronutrients

Vitamins

Oxaliplatin

Fluorouracil

Folic Acid

Vitamin B Complex

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Trace Elements

Folinic Acid

Folate

Vitamin B9

5-FU

Panitumumab maintenance phase (3 months) 9mg/kg BW every 3 weeks

Volker Heinemann, Prof. Dr. med.

Clemens Gießen, Dr. med.

Clemens Giessen, Dr. med.

Up to 50% of patients with colorectal cancer (CRC) develop liver metastasis during the course of their disease. In 30-40% of patients metastasis is confined to the liver. In these patients R0-resection of metastases may contribute to marked improvement of overall survival. Primary resection of liver metastasis is possible in about 15-20% of patients (Scheele 2005, Petrelli 2005). Recent studies indicate that perioperative chemotherapy may improve survival after resection of liver metastases (Portier 2007, Nordlinger 2007). Nevertheless, there is evidence that 70-80% of patients have recurrent disease after resection of liver metastasis. Stratification for the risk of recurrence may be performed using the FONG-score (Fong 1999).

This study is designed to investigate the efficacy of postoperative chemotherapy combined with an anti-EGFR treatment using panitumumab.

The majority of patients present to the surgeon after chemotherapeutic pretreatment with various not necessarily standardized regimens. Also postoperative therapy after resection of liver metastasis is not a clearly defined standard of care in Germany.

Based on the study by Nordlinger et al. an oxaliplatin-based regimen is chosen for postoperative therapy (Nordlinger 2008). For reasons of practicability mFOLFOX6 was selected as the chemotherapy backbone for additive treatment (Allegra 2010).

Also, there is evidence that the combination of FOLFOX with panitumumab is associated with enhanced antitumor activity (Douillard et al. ESMO 2009). The experimental treatment arm will therefore evaluate the combination of FOLFOX plus panitumumab. Since in colorectal cancer monoclonal antibodies directed against the EGFR are not active in KRAS mutant patients, the experimental arm including panitumumab will only be performed in KRAS wild-type patients (Amado 2008).

The planned study aims to assess the efficacy of postoperative therapy with FOLFOX plus panitumumab followed by maintenance with panitumumab for 3 months in KRAS wild-type patients, compared to the historical data for standard FOLFOX chemotherapy alone, which are verified by a randomised control group without the antibody. (Figure 1: Study Design).

The study will allow preoperative treatment with regimens such as FOLFIRI, XELIRI, FOLFOX or XELOX +/-bevacizumab or +/- cetuximab. However, only those patients will be considered eligible who did not progress during preoperative therapy.

After surgery, a treatment-free interval of at least 4 weeks, but no longer than 8 weeks will be granted.

KRAS-wild-type patients (60% of all pts) will then be randomized in a 2:1 ratio to an experimental arm with FOLFOX + panitumumab or to a reference arm with FOLFOX alone. Combination treatment will be performed for a duration of 3 months, after which patients in the experimental arm will receive maintenance therapy with panitumumab for further 3 months. In the reference arm, treatment will, however, be ended after 3 months.

Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients

Amgen

PD Dr. med. Volker Heinemann

Sponsor Delegatated Person

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Sarcoma

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Pegylated liposomal doxorubicin

6 mg/kg on days 1 and 15 of a 28 days cycle

Anders Jakobsen, MD, DMSc

Karina D. Steffensen, MD, PhD

The purpose of this study is to investigate the response rate in platinum-resistant, KRAS wild-type, ovarian cancer patients who are treated with pegylated liposomal doxorubicin (Caelyx®) in combination with biological treatment panitumumab (Vectibix®).

Patients with platinum-resistant recurrent ovarian cancer have few therapeutic options and the response rates are only 10-20% using non-cross-resistant chemotherapeutic agents.

New biologic agents in combination with chemotherapy or other treatment modalities may result in improvement in survival.

Recent results in colorectal cancer have clearly indicated that KRAS mutant tumors do not respond to treatment with EGFR inhibitors.

Panitumumab (ABX-EGF) is the first fully human monoclonal antibody specific to the EGF receptor. To date, panitumumab has been evaluated in combination with chemotherapy in patients with CRC, NSCLC, and SCCHN.

No previous studies have evaluated the effect of panitumumab in epithelial ovarian cancer based on KRAS mutation status.

Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With KRAS Wild-type

Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type

Vejle Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal Cancer	NCT01060423	Colorectal Canc...	Cetuximab Irinotecan Irinotecan elut...	18 Years -	Martin-Luther-Universität Halle-Wittenberg
A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer	NCT02399943	Colorectal Canc... KRAS Wildtype NRAS Wildtype BRAF Wildtype	Trametinib Panitumumab	18 Years -	University Health Network, Toronto
Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients	NCT01384994	Colorectal Canc... KRAS Wildtype After Resection...	Folic Acid 5-FU 5-FU Oxaliplatin Panitumumab Panitumumab Folic Acid 5-FU 5-FU Oxaliplatin	18 Years -	Ludwig-Maximilians - University of Munich
Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients	NCT01384994	Colorectal Canc... KRAS Wildtype After Resection...	Folic Acid 5-FU 5-FU Oxaliplatin Panitumumab Panitumumab Folic Acid 5-FU 5-FU Oxaliplatin	18 Years -	Ludwig-Maximilians - University of Munich
Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With KRAS Wild-type	NCT00861120	Epithelial Ovar...	Pegylated lipos... Panitumumab	18 Years -	Vejle Hospital
A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer	NCT02399943	Colorectal Canc... KRAS Wildtype NRAS Wildtype BRAF Wildtype	Trametinib Panitumumab	18 Years -	University Health Network, Toronto

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