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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT00792363
First received: November 14, 2008
Last updated: June 12, 2012
Last verified: June 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Every 9 weeks. Up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2008
Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
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: 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT00792363     History of Changes
Other Study ID Numbers: EudraCT 2008-004923-48, S-20080104, DKMA 2612-3844
Study First Received: November 14, 2008
Last Updated: June 12, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by Vejle Hospital:
KRAS

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014