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Colorectal Cancer MetastaticPhase 2REGAINNCT02316496

Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study

A Phase 2 study testing cetuximab and Irinotecan in people with Colorectal Cancer Metastatic, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 20 sites in France.

Terminated

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

Official record
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Trial summary

The main objective of this study is to evaluate the objective response rate at two months (complete disappearance of the disease and partial disappearance of the disease) obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
cetuximab and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
20 sitesFrance
Study dates
23 Sep 2015to 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated informed consent
  • Histologically confirmed metastatic adenocarcinoma of the colon or rectum
  • All Wild Type KRAS (exon 2 [codons 12-13], exon 3 [codons - 61]; exon 4 [codon 146]), NRAS (exon 2 [ codons 12-13] and exon 3 [codon 61) and BRAF (V600E) tumor ( local assessment performed either on primary tumor or metastasis)
  • First line chemotherapy regimen with a fluoropyrimidine and Irinotecan (FOLFIRI) + cetuximab with initial partial or complete response and progressive disease (PD) with PD ≤ 6 weeks after the last administration of cetuximab
  • Other line(s) of therapy(ies) including the following drugs: second line oxaliplatin based chemotherapy with fluoropyrimidines (5FU or capecitabine) + bevacizumab and eventually regorafenib (possible but not mandatory) and progression or limiting toxicity to the last therapy with a minimum of 4 months between last injection of cetuximab and inclusion in this study
  • At least one measurable lesion ≥ 10 mm as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1 (All sites must be evaluated ≤ 28 days prior to the enrolment)
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  • Age ≥18 years
  • World Health Organization (WHO) Performance status (PS) 0-2
  • The patient has adequate organ function, defined as :
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL, and platelets ≥ 100 x 109/L.Total bilirubin ≤ 1.5 times upper limit of normal value (ULN), serum alkaline phosphatase level < 5 times ULN, Serum creatinine level <150μM/l
  • For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study drug
  • Men and women are required to use adequate birth control during the study (when applicable) and until 6 months after the end of study treatment
  • Registration in a national health care system (CMU included)

Who cannot join

  • Previous chemotherapy other than adjuvant therapy with different combinations than those scheduled in first and second line treatment
  • Presence of any KRAS, BRAF or NRAS mutation by allelic discrimination on tumor DNA
  • Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiation of study treatment or a history of ventricular arrhythmia (treated or not)
  • History or evidence of central nervous system metastasis (systematic CT-scan or MRI not mandatory if no clinical symptoms)
  • Known allergy or hypersensitivity to cetuximab
  • Previous or concurrent malignancy except for basal or squamous cell skin cancer, in situ carcinoma of the cervix, low-risk prostate cancer according to d'Amico classification or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to the study
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  • Active or uncontrolled clinically serious infection
  • Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness
  • Other serious and uncontrolled non-malignant disease
  • Pregnancy
  • Breast feeding
  • Treatment with any other investigational medicinal product within 28 days prior to study entry
  • Known Gilbert's syndrome
  • Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine
  • Concomitant use with St John's Wort
  • Chronic inflammatory bowel disease and/or Bowel obstruction

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Hôpital Beaujon

    Clichy

  • Centre hospitalier Alpes Leman

    Contamine-sur-Arve

  • Centre Georges François Leclerc

    Dijon

  • CHD Vendée

    La Roche/ Yon

  • Hôpital Privé Jean Mermoz

    Lyon

  • Hôpital Européeen

    Marseille

  • Institut Paoli-Calmettes

    Marseille

  • CHU Caremeau

    Nîmes

  • CHU Cochin

    Paris

  • Hôpital Pitié Salpêtrière

    Paris

  • Hôpital Saint Antoine

    Paris

  • Hôpital Saint Louis

    Paris

  • Hôpital Tenon

    Paris

  • Clinique Armoricaine de Radiologie

    Saint-Brieuc

  • Groupe hospitalier Public du Sud de l'Oise -site de Senlis

    Senlis

  • Centre de radiothérapie - Clinique Sainte Anne

    Strasbourg

  • Hôpital Foch

    Suresnes

  • Hôpitaux du Léman

    Thonon-les-Bains

  • CHU Tours - Hôpital Trousseau

    Tours

  • Clinique Générale

    Valence

Other trials in France

About this study

Official title: A Phase II Study of Cetuximab Rechallenge in Combination With Irinotecan in Advanced Metastatic Colorectal Cancer Without KRAS or NRAS or BRAF Mutation (All Wild Type) for Patients Pretreated With FOLFIRI and Cetuximab in First Line With Stopping Cetuximab for Progressive Disease After a Previous Response (Partial Response or Complete Response) and After Treatment With a Fluoropyrimidine, Oxaliplatin Plus Bevacizumab Regimen

The main objective of this study is to evaluate the objective response rate at two months (complete disappearance of the disease and partial disappearance of the disease) obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer.

Secondaries objectives will be assessed progression-free survival, overall survival, toxicity, quality of life.

Being tested
cetuximab, Irinotecan
Keywords
Cancer, Colorectal, Metastatic, Thrid-line, Irinotecan, Cetuximab
Medical subject headings
Neoplasms, Neoplasm Metastasis

What participants receive

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

  • cetuximabDrug

    cetuximab 500mg/m²/ IV infusion, (q2w)

  • IrinotecanDrug

    Irinotecan 180mg/m², in 500ml NaCl 0.9% solution, 90 min IV infusion (q2w)

Study groups in NCT02316496
Study groupRoleWhat they receive
open label , single armExperimentalcetuximab - irinotecan until progression or unacceptable toxicity
Receives: Drug: cetuximab; Drug: Irinotecan

What is being measured

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

  1. Objective response rate (ORR)

    Measured: At 2 months

Secondary outcomes (13)

  1. Objective response rate (ORR)

    Best response observed during investigational treatment combination. From the start of treatment until treatment failure

    Measured: up to 27 months

  2. Disease control rate (DCR)

    The proportion of patients with tumor response (Complete response or partial response) or tumor stabilization as best response during study treamtent

    Measured: up to 27 months

  3. Progression-free survival (PFS)

    Time from the date of inclusion to the date of the first progressive disease (RECIST criteria) or death (any cause)

    Measured: up to 27 months

  4. Duration of response (DOR)

    Only for patients with tumor response (complete reposne or partial response) , from first confirmed response to first observed progression (PD) or death due to PD during study treatment

    Measured: up to 27 months

  5. Time to response (TTR)

    Time from the date of inclusion to the date of the first confirmed CR or PR during study treatment

    Measured: up to 27 months

  6. Time to progression (TTP)

    Time from the date of inclusion to the date of the first obseved progression (PD), or death due to progression during the study treatment

    Measured: up to 27 months

  7. Time to treatment failure (TTF)

    Time from the date of inclusion to the date the decision was made to end the study treatment for any reason

    Measured: up to 27 months

  8. Duration of stable disease (DoSD)

    Only for patient with a stable disease (SD) as best response during the study treatment, from date of inclusion to the first observed progression (PD) or death due to progression

    Measured: up to 27 months

  9. Overall survival (OS)

    From the date of inclusion to the date of patient death, due to any cause, or to the last date the patient was known to be alive

    Measured: up to 27 months

  10. Adverse Events (CTCAE v.4.03)

    Measured: Up to 27 months

  11. Quality of life

    Using EORTC Quality of Life Questionnaire - C30 (QLQ-C30) and the Dermatology Life Quality Index (DLQI ) questionnaires

    Measured: Up to 27 months

  12. Respose rate

    RAS and BRAF status in circulating tumoral DNA

    Measured: up to 27 months

  13. PFS

    RAS and BRAF status in circulating tumoral DNA

    Measured: up to 27 months

Timeline

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

  1. First posted15 Dec 2014 (estimated)
  2. Study start23 Sep 2015
  3. Primary completionJan 2016
  4. Study completionJan 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02316496
Sponsor's protocol ID
REGAIN C13-2
Acronym
REGAIN
Status last verified
Jan 2017
First submitted
8 Dec 2014
Last updated
1 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab and Irinotecan in people with Colorectal Cancer Metastatic, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 20 sites 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 13 inclusion and 16 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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 was stopped early. 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?

Objective response rate (ORR) (time frame: At 2 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 NCT02316496.

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 1 Aug 2017.

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