AzTrials
AzTrials

Metastatic Colorectal CancerPhase 2NCT01703390

Biomarker Directed Treatment in Metastatic Colorectal Cancer

A Phase 2 study testing FOLFIRI + Cetuximab and modifiedFOLFOX6 + Cetuximab in people with Metastatic Colorectal Cancer, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 11 sites in Austria.

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 pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in metastatic colorectal cancer (mCRC). 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?
FOLFIRI + Cetuximab and modifiedFOLFOX6 + Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
11 sitesAustria
Study dates
4 Dec 2012to 3 Jul 2020
Phase
Phase 2
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

  • 1.1 Inclusion criteria for pre-screening phase:
  • Untreated advanced metastatic colorectal cancer patients
  • Adequate tissue to evaluate for genotyping (10 x 10µm thick formalin fixed paraffin embedded tissue sections and one corresponding HE stained slide or a FFPE tumor block)
  • 1.2 Inclusion criteria for treatment phase:
  • Patients must fulfill all criteria listed below prior to enrolment in the study:
  • Untreated wild-type KRAS metastatic colorectal cancer
Show all 19Show fewer
  • Previous adjuvant therapy must have been completed > 6 months before therapy initiation on this study
  • Age >18 years
  • Measureable disease with CT or MRI
  • ECOG performance status of 0-2
  • Adequate organ function
  • Hematologic:
  • Absolute neutrophil count > 1,500/µL
  • Hemoglobin >9 mg/dl
  • Platelet count >100,000 /µl
  • Renal:
  • Serum creatinine <1.5 x Upper limit of normal (UPN) or estimated clearance > 30 ml/min
  • Hepatic:
  • Serum bilirubin < 1.5 mg/dl

Who cannot join

  • Creatinine clearance below 30 ml/min
  • Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent.
  • Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina.
  • Other known co-morbidity with the potential to dominate survival
  • Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
  • Pregnant or breast feeding women
  • Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Austria11 sites

  • LKH Bludenz Innere Medizin

    Bludenz, 6700

  • LKH Bregenz

    Bregenz, 6900

  • KH Dornbirn, Innere Medizin

    Dornbirn, 6850

  • LKH Feldkirch, Interne E

    Feldkirch, Vorarlberg, 6807

  • Universitätsklinikum Graz

    Graz, 8036

  • LKH Hohenems, Interne Intensivmedizin

    Hohenems, 6845

  • A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie

    Kufstein, Tyrol, 6330

  • KUK Linz - Med Campus III.: Univ.-Klinik für Hämatologie und Internistische Onkologie

    Linz, Upper Austria, 4021

  • Krankenhaus d. Barmherzigen Schwestern Linz

    Linz, A-4010

  • Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum

    Salzburg, 5020

  • Medizinische Universität Wien, Univ.Klinik für Innere Medizin I, Abteilung für Onkologie

    Vienna, 1090

Other trials in Austria

About this study

Official title: Pilot Study: Biomarker Directed Treatment in Metastatic Colorectal Cancer

This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in metastatic colorectal cancer (mCRC). In wild type KRAS mCRC patients treated with either FOLFOX or FOLFIRI in combination with cetuximab the median response rate is approximately 60-65%. Biomarker directed treatment in this study may demonstrate that patients with low ERCC-1 treated with FOLFOX and cetuximab, and those with high ERCC-1 treated with FOLFIRI and cetuximab, will improve response rate to 70-75%. KRAS wild type patients will be treated with 6 cycles of one of the following regimens chosen for optimization based on patient characteristics (primary treatment phase). Patients with ERCC-1 < 1.7 relative gene expression of ERCC-1 over ß-actin (ERCC-1 low) will be assigned to treatment with mFOLFOX6 in combination with Cetuximab. Patients with ERCC-1 gene expression > 1.7 relative gene expression of ERCC-1 over over ß-actin (ERCC-1 high) will be assigned to treatment with FOLFIRI in combination with Cetuximab.

Being tested
FOLFIRI + Cetuximab, modifiedFOLFOX6 + Cetuximab
Keywords
metastatic colorectal cancer, mCRC, ERCC-1, ERCC1, AGMT
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • FOLFIRI + CetuximabDrug

  • modifiedFOLFOX6 + CetuximabDrug

Study groups in NCT01703390
Study groupRoleWhat they receive
ERCC-1 lowExperimentalmodifiedFOLFOX6 + Cetuximab oxaliplatin 85 mg/m2 on day 1, 15 q d29 for 6 cycles folinic acid (FA) 400 mg/m2 on days 1 and 15 and q d29 for 6 cycles fluorouracil (5-FU) 400 mg/m2 bolus day 1 + 2400 mg/m2 46-hour infusion on days 1, 2 and 15, 16 and q d29 for 6 cycles or until unacceptable toxicity Cetuximab will be administered as a 120- minute intravenous infusion at 500 mg/m2 on day 1 then 500 mg/m2 bi-weekly
Receives: Drug: modifiedFOLFOX6 + Cetuximab
ERCC-1 highExperimentalFOLFIRI + Cetuximab irinotecan 180 mg/m² on day 1, 15 q d29 for 6 cycles folinic acid (FA)400 mg/m2 on days 1 and 15 and q d29 for 6 cycles fluorouracil (5-FU) 400 mg/m2 bolus + 2400 mg/m2 46-hour infusion on days 1, 2 and 15, 16 and q d29 for 6 cycles or until unacceptable toxicity Cetuximab will be administered as a 120- minute intravenous infusion at 500 mg/m2 on day 1 then 500 mg/m2 bi-weekly
Receives: Drug: FOLFIRI + Cetuximab

What is being measured

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

  1. Response

    Treatment response according to Response Evaluation Criteria In Solid Tumors [RECIST]

    Measured: 5 years

Secondary outcomes (6)

  1. Progression free survival (PFS)

    Measured: 5 years

  2. Response rate

    Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to response rate, PFS and OS

    Measured: 5 years

  3. Patient characteristics

    Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to KRAS status

    Measured: 5 years

  4. Secondary resection rate

    Measured: 5 years

  5. Molecular markers for toxicity

    Measured: 5 years

  6. Number of adverse events during study treatment

    Measured: 5 years

Timeline

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

  1. First posted10 Oct 2012 (estimated)
  2. Study start4 Dec 2012
  3. Primary completion23 Feb 2018
  4. Study completion3 Jul 2020

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01703390
Sponsor's protocol ID
AGMT_ERCC1
Other IDs
2011-003217-41
Status last verified
Dec 2020
First submitted
4 Oct 2012
Last updated
21 Dec 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFIRI + Cetuximab and modifiedFOLFOX6 + Cetuximab in people with Metastatic Colorectal Cancer, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 11 sites in Austria.

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 19 inclusion and 7 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Austria. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 (time frame: 5 years). 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 NCT01703390.

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 21 Dec 2020.

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