Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792363
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Irinotecan Drug: Panitumumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations
Study Start Date : November 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Irinotecan
    350 mg/m2 intravenously on day 1 every 3 weeks
  • Drug: Panitumumab
    9 mg/kg intravenously on day 1 every 3 weeks

Primary Outcome Measures :
  1. Response Rate [ Time Frame: Every 9 weeks. Up to 6 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 6 months ]
  2. Progression free survival [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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: Neutrophilocytes ≥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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792363

Vejle Hospital, Dept. of Oncology
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
Study Chair: Anders Jakobsen, Professor Vejle Hospital

Responsible Party: Vejle Hospital Identifier: NCT00792363     History of Changes
Other Study ID Numbers: EudraCT 2008-004923-48
DKMA 2612-3844
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Vejle Hospital:

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs