Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations - Full Text View

Sponsored by:	Vejle Hospital
Information provided by:	Vejle Hospital
ClinicalTrials.gov Identifier:	NCT00792363

Purpose

The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.

Condition	Intervention	Phase
Metastatic Colorectal Cancer	Drug: Irinotecan Drug: Panitumumab	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Panitumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Safety/Efficacy Study
Official Title:	A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:

Response Rate

Secondary Outcome Measures:

Overall survival
Progression free survival
Toxicity
Identification of prognostic and predictive markers in relation to translational research

Estimated Enrollment:	39
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Detailed Description:

Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy.

In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as combination or mono therapy. In recent years biological antibodies targeted against EGFR have been added to this treatment. A newly developed antibody is Panitumumab, which enables treatment every 3 weeks instead of weekly administration.

The effect of EGFR activation is mediated through intracellular pathways involving the KRAS protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly activated, and patients with these mutations do not benefit from antibodies against EGFR. Approximately 40% of the patients present these mutations.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically verified adenocarcinoma in colon or rectum with metastatic spread.
No mutations in the KRAS gene.
Resistance to 5-FU, oxaliplatin and irinotecan.
Age ≥18 years.
PS 0-2.
Measurable disease according to RECIST criteria.
Haematology: Neutrofilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old.
Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
Oral and written informed consent.

Exclusion Criteria:

Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
Verified or clinically suspected CNS metastasis.
Other experimental treatment.
Serious medical disease according to investigator's judgement.
Pregnant or breastfeeding women.
Hypersensitivity to the active substance or to one or more of the auxiliary substances.
Patients with interstitial pneumonitis or pulmonary fibrosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792363

Contacts

Contact: Anders Jakobsen, Professor		anders.jakobsen@slb.regionsyddanmark.dk
Contact: Torben Hansen, MD		torben.hansen@slb.regionsyddanmark.dk

Locations

Denmark
Vejle Hospital, Dept. of Oncology	Recruiting
Vejle, Denmark, DK-7100
Contact: Torben Hansen, MD torben.hansen@slb.regionsyddanmark.dk
Principal Investigator: Torben Hansen, MD
Sub-Investigator: Karen-Lise Spindler, MD, PhD
Sub-Investigator: John Ploen, Consultant

Sponsors and Collaborators

Vejle Hospital

Investigators

Study Chair:

Anders Jakobsen, Professor

Vejle Hospital

More Information

Responsible Party:	( Professor, MD, DMSc Anders Jakobsen )
Study ID Numbers:	EudraCT 2008-004923-48, S-20080104, LMS 2612-3844
Study First Received:	November 14, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00792363
Health Authority:	Denmark: National Board of Health

Keywords provided by Vejle Hospital:

KRAS

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Irinotecan
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009