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Metastatic Colorectal CancerPhase 2NCT01919879

Dual Targeting of EGFR With Cetuximab and Afatinib to Treat Refractory wtKRAS Metastatic Colorectal Cancer

A Phase 2 study testing Cetuximab + Afatinib and Cetuximab in people with Metastatic Colorectal Cancer, run by UNICANCER at 1 site in France.

Completed

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

Official record
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Trial summary

This is a multicentric, phase II and open label study.75 patients are expected to be randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS metastatic colorectal cancer. 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?
Cetuximab + Afatinib and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteFrance
Study dates
Oct 2012to Dec 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic colorectal cancer expressing the wtKRAS status
  • No previous EGFR targeted therapy.
  • Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease
  • Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)
  • Life expectancy of at least 3 months.
  • Patient with ECOG ≤ 1
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  • Patients aged ≥ 18.
  • Patient with measurable lesions according to RECIST criteria (version 1.1) with spiral CT scan and defined as ≥ 10 mm in longest diameter and 2X the slice thickness for extra nodal lesions and/or > 15 mm in short axis diameter for nodal lesions
  • Patient able to receive adequate oral nutrition of ≥ 1500 calories per day and free of significant nausea and vomiting
  • Patient with adequate organ function:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Haemoglobin ≥ 9 g/dL
  • Platelets (PTL) ≥ 100 x 109/L
  • AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastases)
  • GammaGT < 3 x ULN (< 5 x ULN in case of liver involvement)
  • Bilirubin ≤ 1.5 x ULN
  • Creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
  • Adequate contraception if applicable.
  • Ability to take oral medication in the opinion of the investigator
  • Patient able and willing to comply with study procedures as per protocol
  • Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
  • Patient affiliated to a social security regimen

Who cannot join

  • Previous EGFR targeted therapy.
  • Mutant KRAS status
  • Prior severe reaction to a monoclonal antibody
  • No heart failure or coronary heart disease symptoms Clinically relevant cardiovascular abnormalities, as judged by the investigator, such as, but not limited to, uncontrolled hypertension, congestive heart failure NYHA classification > III, unstable angina, myocardial infarction within six months prior to randomisation, or poorly controlled arrhythmia
  • Cardiac left ventricular dysfunction with resting ejection fraction of less than institutional lower limit of normal (if no lower limit of normal is defined in the institution, the lower limit is 50%)
  • Symptomatic brain metastases requiring treatment
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  • Major surgery within 28 days or minor surgery within 14 days of the start of the study treatment
  • Radiotherapy less than two weeks prior to the start of the study treatment
  • Systemic chemotherapy, hormonal therapy, immunotherapy ≤ 21 days before study treatment
  • No major comorbidity that may preclude the delivery of treatment or active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes.
  • Concomitant occurrence of another cancer, or history of cancer within the past five years except in situ carcinoma of the cervix treated or basal cell carcinoma or squamous cell carcinoma.
  • Known pre-existing interstitial lung disease
  • Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, malabsorption, or CTCAE grade >2 diarrhea of any etiology
  • Pregnant woman or lactating woman.
  • Persons deprived of liberty or under guardianship.
  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Previous history of keratitis, ulcerative keratitis or severe dry eye.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institute de Cancérologie de la Loire

    Nantes, 44805

Other trials in France

About this study

Official title: A Multicentric Randomized Phase II Trial Evaluating Dual Targeting of EGFR Using the Combination of Cetuximab and Afatinib Versus Cetuximab Alone in Patients With Chemotherapy Refractory wtKRAS Metastatic Colorectal Cancer

This is a multicentric, phase II and open label study.75 patients are expected to be randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS metastatic colorectal cancer.

Read the detailed description

Patients who will sign the inform consent will be enrolled into one of two groups. Group A will receive Afatinib ( 40mg per day) and Cetuximab (500mg/m2)every two weeks until progression. Group B will receive Cetuximab (500mg/m2) alone every two weeks until progression and after progression,patients from group B will receive afatinib (group A treatment) until progression. The criteria for evaluation will be tumor response and progression documented by CT scan and according to RECIST criteria version 1.1.

Patient will also sign a inform consent before participating in biological study. The aim of this translational study is to collect tumor and blood sample in order to determine, the biological factors which are predictive of the response to treatment.

Being tested
Cetuximab + Afatinib, Cetuximab
Keywords
Chemotherapy refractory, wtKRAS metastatic colorectal cancer, cross over
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Cetuximab + AfatinibDrug

    Also called Erbitux

    Afatinib taken orally, cetuximab administered intravenously

  • CetuximabDrug

    Also called Erbitux

    Cetuximab administered intravenously

Study groups in NCT01919879
Study groupRoleWhat they receive
Arm A: Cetuximab + AfatinibExperimentalAfatinib 40 mg daily Cetuximab 500 mg/m2 every 2 weeks until progression
Receives: Drug: Cetuximab + Afatinib
Arm B : Cetuximab aloneActive comparatorCetuximab 500mg/m2 every 2 weeks until progression After progression: Cetuximab 500mg/m2 + Afatinib 40 mg per day until progression
Receives: Drug: Cetuximab + Afatinib; Drug: Cetuximab

What is being measured

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

  1. Non progression rate at 6 months

    The progression rate is defined as percentage of patients without progression at 6 months after observation of all patients at 6 months

    Measured: 6 months

Secondary outcomes (5)

  1. Overall response rate (OR)

    Overall response rate is defined as percentage of subjects with a confirmed complete or partial response as per RECIST V1.1 criteria

    Measured: 6 months

  2. Progression free survival

    It is define as the time of from randomization to date of first documented progression or any cause of death

    Measured: until progression or death, expected average approximately 4 months

  3. Overall and specific survival

    Overall and specific survival is defined from time of randomization to the date of documented death

    Measured: until death, on average approximately 14 months

  4. Quality of life

    EORTC QLQ-C30 and QLQ-CR29 are questionnaires developed to assess the quality of life of cancer patients

    Measured: During treatment, on average approximately 4 months

  5. Tolerance of the treatment

    Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs)

    Measured: until progression, expected approximately 4 months

Timeline

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

  1. First posted9 Aug 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionNov 2015
  4. Study completionDec 2017

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
Crossover
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01919879
Sponsor's protocol ID
UCGI 25
Status last verified
May 2018
First submitted
1 Mar 2013
Last updated
8 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab + Afatinib and Cetuximab in people with Metastatic Colorectal Cancer, run by UNICANCER at 1 site in France.

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 22 inclusion and 17 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 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Non progression rate at 6 months (time frame: 6 months). 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 NCT01919879.

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 8 May 2018.

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