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

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792363
• Other study ID #: EudraCT 2008-004923-48
• Secondary ID: S-20080104DKMA 2
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2008
• Last updated: June 12, 2012
• Start date: November 2008
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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

Locations

Country	Name	City	State
Denmark	Vejle Hospital, Dept. of Oncology	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		Every 9 weeks. Up to 6 months	No
Secondary	Overall survival		6 months	No
Secondary	Progression free survival		6 months	No