Biomarker - Panitumumab Response With KRAS Wild Type MCC

NCT00853931 | Completed

• 3 other identifiers: CA-2008-0012KRAS wild typemetastatic colorectal cancer
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

Brief Summary

This is an exploratory study in which all eligible subjects are given Panitumumab according to the dose and schedule approved by Health Canada. The purpose of this research study is to determine whether the presence of certain biomarkers (substances measurable in blood, normal cells or tumour tissue) are associated with an increased or decreased chance of benefit from panitumumab.

Conditions

Metastatic Colorectal Cancer

Keywords

KRAS wild type; metastatic colorectal cancer; KRAS wild type metastatic colorectal cancer with no prior exposure to EGFR inhibitors

Outcome Measures

Primary Outcomes (1)

• Response rate

  1 year

Secondary Outcomes (3)

• Clinical Benefit Rate

  1 year

• Progression free survival (PFS)

  1 year

• Overall survival

  1 year

Study Arms (1)

Panitumumab

EXPERIMENTAL

Panitumumab 6 mg/kg will be administered by intravenous infusion every 2 weeks (Q2W), +/- 3 days, (eg, week 1, 3, 5 \[i.e. Cycles 1, 2, 3, etc.\]) until disease progression or intolerance panitumumab as determined by the investigator.

Drug: Panitumumab

Interventions

Panitumumab DRUG

Panitumumab 6 mg/kg will be administered by intravenous infusion every 2 weeks (Q2W), +/- 3 days, (eg, week 1, 3, 5 \[i.e. Cycles 1, 2, 3, etc.\]) until disease progression or intolerance panitumumab as determined by the investigator.

Panitumumab

Eligibility Criteria

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

You may qualify if:

• Histological proof of adenocarcinoma of colon or rectum. In addition, proof either radiologically, or histologically that there is metastatic disease.
• Archival, paraffin embedded tumour tissue block suitable for KRAS and biomarker, or, willingness to undergo biopsy to obtain such.
• Received a prior thymidylate synthase inhibitor (e.g. 5-fluorouracil (5- FU), capecitabine, raltitrexed) for adjuvant and/or metastatic disease. Thymidylate synthase inhibitor may have been given in combination with oxaliplatin or irinotecan.
• Received or ineligible for irinotecan based therapy (i.e. single-agent or in combination) for metastatic disease
• Received or ineligible for oxaliplatin based therapy for metastatic and/or adjuvant disease.
• Measurable or evaluable disease by RECIST criteria.
• Adequately recovered from recent surgery, chemotherapy and/or radiation therapy. At least 4 weeks must have elapsed from major surgery, prior chemotherapy, and prior treatment with an investigational agent or prior radiation therapy.
• Must not have received any prior anti-EGFR therapies including tyrosine kinase inhibitors or monoclonal antibodies.
• An ECOG performance status of 0, 1 or 2.
• Hematology done within 14 days and with initial values within the ranges specified below:
• Absolute granulocyte count (AGC) \> 1.5 x 109/L
• Platelets \> 100 x 109/L
• Hemoglobin \> 100 g/L
• Biochemistry done within 14 days and with initial values within the ranges specified below:
• Total bilirubin \< 2.5 x institutional upper limit of normal

You may not qualify if:

• Known hypersensitivity to panitumumab or any other component of the product; life-threatening infusion reactions associated with previous administration of monoclonal antibody therapy.
• Women who are pregnant or breastfeeding, or intend to become pregnant within the study period
• Any active pathological condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
• Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
• Significant history of uncontrolled angina, arrhythmias, cardiomyopathy, congestive heart failure, or documented myocardial infarction within the 6 months preceding registration (pre-treatment ECG evidence only of infarction will not exclude patient).
• Symptomatic metastases in the central nervous system.
• A history of prior cetuximab or other therapy which targets the Epidermal Growth Factor Receptor pathway (e.g. TarcevaTM (OSI-774), IressaTM (ZD1839), or others). A history of prior murine monoclonal antibody therapy (e.g. EdrecolomabTM (MoAB17-1A), or others).
• Severe restrictive lung disease or radiological pulmonary findings of "interstitial lung disease" on the baseline chest x-ray which, in the opinion of the investigator, represents significant pathology.
• Receipt of an experimental therapeutic agent within the past 30 days.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (3)

BC Cancer Agency - Abbotsford

Abbotsford, British Columbia, V2S 0C2, Canada

Location

BCCA- Fraser Valley

Surrey, British Columbia, V3V 1Z2, Canada

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hagen Kennecke, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

CA (3)