AzTrials
AzTrials

Metastatic Colorectal CancerNCT00853931

Biomarker - Panitumumab Response With KRAS Wild Type MCC

A study testing Panitumumab in people with Metastatic Colorectal Cancer, run by British Columbia Cancer Agency at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Panitumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
3 sitesCanada
Study dates
Oct 2009to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 27Show fewer
  • 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
  • ALT < 5.0 x institutional upper limit of normal
  • AST < 5.0 x institutional upper limit of normal
  • Serum creatinine < 1.5 x institutional upper limit of normal
  • Imaging investigations including chest x-ray and CT/MRI of abdomen/pelvis or other scans as necessary to document all sites of disease done within 28 days prior to randomization. Where chest x-ray is suspicious for or reveals metastatic disease, a CT/MRI scan of the chest must also be performed. A CT/MRI scan of the chest within 28 days prior to randomization may be substituted for chest x-ray.
  • ECG done within 28 days prior to enrollment
  • Patient's age is >18 years.
  • Women of child bearing potential (WOCBP) and male partners of WOCBP must agree to use adequate contraception prior to study entry, throughout the study and for a period of 6 months after cessation of protocol therapy.
  • Adequate contraception is defined as follows:
  • Complete abstinence from intercourse from four weeks prior to administration of the first dose until 6 months after the final dose of panitumumab
  • Consistent and correct use of one of the following methods of birth control: i. male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; or ii. implants of levonorgesterol; or iii. injectable progestagen; or iv. any intrauterine device (IUD) with a documented failure rate of less than 1% per year; or v. oral contraceptive pill (either combined or progesterone only); or vi. barrier methods including diaphragm or condom with a spermicide.
  • The baseline assessment must be completed within 14 days prior to randomization.
  • Patients must be accessible for treatment and follow-up.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • BC Cancer Agency - Abbotsford

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • BCCA- Fraser Valley

    Surrey, British Columbia, V3V 1Z2

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: An Exploratory Trial of Biomarkers for Panitumumab Response Among Previously Treated Patients With KRAS Wild Type Metastatic Colorectal Cancer.

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.

Read the detailed description

Colon cancer affects 20,000 Canadians a year. Despite efforts to improve screening, 8,500 patients will die of the disease (1). The agents used in both the adjuvant and metastatic setting have dramatically changed over the past ten years. Even with the optimal treatment and careful follow-up many patients will develop metastasis. For most this is an incurable condition and the median survival for these patients is only 2 years (2).

Therapy with 5-Fluorouracil (FU)/Leucovorin, oxaliplatin and irinotecan with or without bevacizumab are conventionally used as first and second line therapy for metastatic colorectal cancer. Third line therapy options are limited to anti-epidermal growth factor receptor (EGFR) therapy Cetuximab or Panitumumab either as monotherapy or in combination with Irinotecan. Recent data (see Table 1) has demonstrated that KRAS mutation status is a predictor of benefit to anti-EGFR therapy, with wild-type tumours demonstrating a response rate of 10-17% to monotherapy while a 0% response rate is observed among KRAS mutant tumours.

The purpose of this exploratory study is to examine the correlation of biomarkers (PTEN, BRAF, amphiregulin, c-MET, EGFR) with response rate among patients with KRAS wild type tumours treated with panitumumab. If a high response subgroup can be identified, this may support the use of Panitumumab with combination therapy in the first line setting. Secondary objectives are to determine the prognostic and predictive value of CTCs for patients treated with single agent panitumumab and to describe overall survival (OS) and progression free survival (PFS) in registered patients.

Being tested
Panitumumab
Keywords
KRAS wild type, metastatic colorectal cancer, KRAS wild type metastatic colorectal cancer with no prior exposure to EGFR inhibitors
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PanitumumabDrug

    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.

Study groups in NCT00853931
Study groupRoleWhat they receive
PanitumumabExperimentalPanitumumab 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.
Receives: Drug: Panitumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Measured: 1 year

Secondary outcomes (3)

  1. Clinical Benefit Rate

    Measured: 1 year

  2. Progression free survival (PFS)

    Measured: 1 year

  3. Overall survival

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00853931
Sponsor's protocol ID
CA-2008-0012
Other IDs
KRAS wild type, metastatic colorectal cancer
Status last verified
Nov 2015
First submitted
26 Feb 2009
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Panitumumab in people with Metastatic Colorectal Cancer, run by British Columbia Cancer Agency at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00853931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in