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Metastatic Colorectal CancerPhase 2NCT01718808

Cetuximab for Elderly Patients With mCRC

A Phase 2 study testing Cetuximab and Capecitabine in people with Metastatic Colorectal Cancer, run by Swiss Cancer Institute at 14 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

OBJECTIVE: The objective of the trial is to judge on the benefit obtained by an upfront cetuximab treatment delivered as monotherapy or as part of a combination treatment with capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type and B-type Raf… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Cetuximab and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
14 sitesSwitzerland
Study dates
Nov 2012to Jan 2017
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patient has given written informed consent before any trial specific treatment
  • Histological proven diagnosis of colorectal cancer, metastatic or inoperable advanced, not amenable to curative therapy
  • Measurable disease, defined as at least one lesion (outside of irradiated areas) that can be measured in at least one dimension as ≥ 10 mm (≥ 15 mm in case of lymph nodes) according to RECIST v1.1
  • Tumour with wild-type KRAS and wild-type BRAF gene
  • No previous systemic chemotherapy for metastatic disease (previous adjuvant chemotherapy is allowed if completed >6 months before randomization, previous rectal radio-chemo therapy if completed >1 month before randomization)
  • WHO performance status 0 or 1
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  • Age >75 years; or: age ≥ 70 years with at least one of the following factors:
  • Any functional dependence as measured by Instrumental Activities of Daily Life (IADL). Significant comorbidity according to the Cumulative Illness Rating Scale for geriatric patients (CIRS-G; any severe comorbidity > grade 3 or a total score > 5 qualifies)
  • Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
  • Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN) (unless known Gilbert-Meulengracht syndrome), aspartate aminotransferase (AST)<2.5xULN
  • Calculated creatinine clearance ≥ 30 ml/min. (according to the formula of Cockcroft-Gault)
  • Patient is able to swallow oral medication
  • Baseline Quality of Life forms have been completed

Who cannot join

  • Documented or suspected cerebral and/or leptomeningeal metastases (no cerebral baseline imaging required in asymptomatic patients)
  • Risk of rapid deterioration due to tumor symptoms or tumor complications
  • Synchronous or prior malignancy other than adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix, other malignancies unless disease free > 2 years
  • Prior anti-EGFR (Epidermal Growth Factor Receptor) antibody therapy
  • Severe or uncontrolled cardiovascular disease (e.g. acute coronary syndromes, cardiac failure NYHA (New York Heart Association) III or IV, clinically relevant myopathy, history of myocardial infarction within the last 12 months, significant arrhythmias)
  • Concurrent severe uncontrolled medical illness (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled infection, uncontrolled diabetes mellitus, active autoimmune disease)
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  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drug
  • Definite contraindications for the use of corticosteroids or antihistamines as premedication
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome or history of inflammatory intestinal disease, or other disease which could alter drug absorption
  • Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QL forms, or interfering with compliance with oral drug intake
  • Any concomitant drugs contraindicated for use with the trial drugs according to the Swissmedic approved product information
  • Concurrent treatment with other experimental drugs or other anti-cancer therapy and/or treatment in a clinical trial within 30 days prior to randomization

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Switzerland14 sites

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Inselspital, Bern

    Bern, CH-3010

  • Spitalzentrum Biel

    Biel, CH-2501

  • Hopital Fribourgeois

    Fribourg, 1708

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital Luzern

    Lucerne, 6000

  • Kantonsspital Muensterlingen

    Muensterlingen, 8596

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • SpitalSTS AG Simmental-Thun-Saanenland

    Thun, 3600

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • Stadtspital Triemli

    Zurich, 8063

  • Klinik Hirslanden

    Zurich, CH-8032

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: Cetuximab Monotherapy and Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With KRAS- and BRAF Wild-type Metastatic Colorectal Cancer. A Multicenter Phase II Trial

OBJECTIVE: The objective of the trial is to judge on the benefit obtained by an upfront cetuximab treatment delivered as monotherapy or as part of a combination treatment with capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type and B-type Raf kinase (BRAF) wild-type metastatic colorectal cancer (mCRC).

Read the detailed description

Primary endpoint: If in a treatment arm the number of patients alive and without progression at 12 weeks is 17 or more, this arm will be considered promising, otherwise not promising. Additionally, a two-sided 95% confidence interval for the difference in Progression free survival (PFS) rates between the two arms will be calculated.

Secondary endpoints and patient characteristics:

  • Laboratory values may be expressed as the absolute values (continuous variables) or/and as grading (ordinal categorical variables).
  • Generally for each categorical variable the results will be summarized by frequencies and percentages. For response rates 95% Clopper-Pearson confidence intervals will be calculated.
  • For each adverse event, the results will be summarized by frequencies and percentages of different grades among all cycles as well as by frequencies and percentages of the within-patient worst grades
  • For each continuous variable the results will be summarized by descriptive statistics.
  • Time-to-event variables will be presented by Kaplan-Meier curves and summarized by medians and 95% confidence intervals.
  • All analysis will be done by treatment arm.
Being tested
Cetuximab, Capecitabine
Keywords
Metastatic Colorectal Cancer, KRAS, BRAF, Wild-type Metastatic, Cetuximab, Capecitabine, Phase II Trial, Elderly Patients
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • CetuximabDrug

    Also called Erbitux

    Cetuximab 500 mg/m2 every second week (days 1, 15, 29, etc.) until progression or unacceptable toxicity

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1000 mg/m2 bid p.o. (750 mg/m2 if creatinine clearance 30-50 ml/min according to Cockroft-Gault formula, on days 1-14 every 3 weeks, restart on day 22

Study groups in NCT01718808
Study groupRoleWhat they receive
Arm A: CetuximabActive comparatorCetuximab 500 mg/m2 every 2 weeks
Receives: Drug: Cetuximab
Arm B: Cetuximab and CapecitabineActive comparatorCetuximab 500 mg/m2 every 2 weeks plus Capecitabine 1000 mg/m2 (*) bid d1-14 every 3 weeks * 750 mg/m2 if creatinine-clearance 30-50 ml/min
Receives: Drug: Cetuximab; Drug: Capecitabine

What is being measured

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

  1. Progression free survival in week 12

    A progression event is defined as (whichever occurs first):

    • Progressive disease (PD) assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    • Death of any cause
    • Starting of second line treatment
    • No tumor assessment 85 days (+/- 7 days) after registration which shows stabilisation or response Patients without tumor assessment at week 12 but with a later assessment showing absence of progression without subsequent treatment will be counted as a progression free at week 12

    Measured: in week 12

Secondary outcomes (6)

  1. Quality of life (QL)

    Measured: Baseline, in week 7, 13 and 19

  2. Adverse events (CTCAE v 4.0)

    Measured: Adverse events are assessed by Common terminology criteria for adverse events (CTCAE) v4.0. From randomization until 30 days after end of treatment (estimated up to 2 years).

  3. Overall Response (OR)

    Measured: Before start of treatment. In week 13 and every 12 weeks up to 2 years.

  4. Progression free survival (PFS)

    Measured: PFS will be calculated sustained from randomization until documented PD or death, whichever occurs first (estimated up to 2 years).

  5. Overall Survival (OS)

    Measured: Overall survival will be calculated from randomization until death (estimated up to 2 years).

  6. Overall treatment utility (OTU) (predefined composite endpoint including clinical benefit, tolerability and acceptability of the treatment)

    Measured: Until week 19.

Timeline

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

  1. First posted31 Oct 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2015
  4. Study completionJan 2017

Why it stopped: FU for 3 years from randomization as initially planned is stopped as we do not expect any changes to the endpoints in the future after one year of FU.

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01718808
Sponsor's protocol ID
SAKK 41/10
Status last verified
Jan 2017
First submitted
22 Oct 2012
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab and Capecitabine in people with Metastatic Colorectal Cancer, run by Swiss Cancer Institute at 14 sites in Switzerland.

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 13 inclusion and 13 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: stopped early, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Switzerland. 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 was stopped early (reason given: FU for 3 years from randomization as initially planned is stopped as we do not expect any changes to the endpoints in the future after one year of FU.). Results are not available in the source record.

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?

Progression free survival in week 12 (time frame: in week 12). 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 NCT01718808.

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 24 Jan 2017; AzTrials last refreshed its copy on 1 Nov 2026.

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