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

NCT00792363 | Completed Phase 2 DMC

• 3 other identifiers: EudraCT 2008-004923-48S-20080104DKMA 2612-3844
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

KRAS

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Every 9 weeks. Up to 6 months

Secondary Outcomes (2)

• Overall survival

  6 months

• Progression free survival

  6 months

Interventions

Irinotecan DRUG

350 mg/m2 intravenously on day 1 every 3 weeks

Panitumumab DRUG

9 mg/kg intravenously on day 1 every 3 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital, Dept. of Oncology

Vejle, DK-7100, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Anders Jakobsen, Professor

  Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 17, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2011
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

DK (1)