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Colorectal CancerPhase 2NCT00755534

Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC

A Phase 2 study testing Irinotecan, Capecitabine and Cetuximab in people with Colorectal Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.

Terminated

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

Official record
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Trial summary

This phase II study will evaluate which is the best way to administer cetuximab after recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment. Read more about this study

Who is it for?
Ages 18 to 72 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Irinotecan, Capecitabine and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
10 sitesGreece
Study dates
Nov 2008to Nov 2008
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 to 72 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed locally advanced or metastatic colorectal cancer
  • Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
  • ECOG performance status ≤ 2
  • Age 18 - 72 years
  • Patients who have had a CR, PR or SD after 1st line therapy based on Irinotecan+Bevacizumab
  • Paraffin block from the primary tumor in order to perform tha mutational analysis of the KRAS gene
Show all 9Show fewer
  • Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit),renal (Creatinine ≤ 1.5 upper normal limit) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
  • Patients must be able to understand the nature of this study
  • Written informed consent

Who cannot join

  • Presence of central nervous system or brain metastases
  • Pregnant or lactating woman
  • Life expectancy < 3 months
  • Previous radiotherapy within the last 4 weeks or > 25% of bone marrow or in the field where the treatment target is located
  • Peripheral neuropathy grade ≥2
  • Known hypersensitivity to Erbitux
Show all 11Show fewer
  • Metastatic infiltration of the liver >50%
  • Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy
  • Active infection
  • Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
  • Psychiatric illness or social situation that would preclude study compliance

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Greece10 sites

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology

    Alexandroupoli

  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

    Athens

  • 401 Military Hospital of Athens

    Athens

  • Air Forces Military Hospital of Athens

    Athens

  • IASO" General Hospital of Athens, 1st Dep of Medical Oncology

    Athens

  • University Hospital of Heraklion, Dep of Medical Oncology

    Heraklion, Crete

  • State General Hospital of Larissa

    Larissa

  • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

    Piraeus

  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

    Thessaloniki

  • Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

    Thessaloniki

Other trials in Greece

About this study

Official title: A Parallel Phase II Study With Irinotecan/Cetuximab (Until PD) Followed by XELOX/Cetuximab (Until PD) vs the Reverse Sequence in Metastatic CRC With Previous Benefit on Irinotecan/Bevacizumab Based Therapy

This phase II study will evaluate which is the best way to administer cetuximab after recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment.

Read the detailed description

Because of the recent advances in the field of systemic chemotherapy for mCRC, like irinotecan, oxaliplatin, capecitabine, and targeted agents (Cetuximab, Bevacizumab) mCRC patients have an overall survival that in some cases reaches 25 months.Irinotecan is an inhibitor of the DNA enzyme topoisomerase I, with use in clinical practice for the last 10 years.In a phase II study with mCRC patients resistant to irinotecan based therapy the combination of irinotecan and Cetuximab (an IgG1 anti-EGFR antibody) yielded a response rate of 22.5%.Capecitabine was shown to have improved tolerability and response rate compared with bolus 5-FU, with comparable time to progression and survival.Oxaliplatin has been approved by the FDA for 2nd line treatment in the metastatic CRC setting as a number of trials have shown promising data for response rates, disease stabilization rates,median progression free survival (PFS) and overall survival (OS).KRAS is a predictive marker for clinical benefit from EGFR-based antibody treatment. KRAS is the first molecular marker for selection of a targeted therapy in combination with a standard chemotherapy regimen. Patients with KRAS wild-type tumors have a strong benefit from the administration of cetuximab with better PFS and objective responses.

Keywords
Metastatic colorectal cancer, Second line, Irinotecan, Cetuximab (Erbitux), Capecitabine (Xeloda)
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • IrinotecanDrug

    Also called CPT-11, Campto

    Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine (p.o) 2000 mg/m2 (1000 mg/m2 x 2) on day 1-7 every 2 weeks until progression

  • CetuximabDrug

    Also called Erbitux

    Cetuximab(IV) 500 mg/m2 on day 1 every two weeks until progression

  • OxaliplatinDrug

    Also called Eloxatin, LoHP

    Oxaliplatin (I.V) 85 mg/m2 on day 1 every two weeks until progression

Study groups in NCT00755534
Study groupRoleWhat they receive
1ExperimentalIrinotecan+Erbitux -> XELOX+Erbitux
Receives: Drug: Irinotecan; Drug: Capecitabine; Drug: Cetuximab; Drug: Oxaliplatin
2ExperimentalXELOX+Erbitux ->Irinotecan+Erbitux
Receives: Drug: Irinotecan; Drug: Capecitabine; Drug: Cetuximab; Drug: Oxaliplatin

What is being measured

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

  1. Time To Progression

    Measured: 1 year

Secondary outcomes (4)

  1. Objective Response Rate

    Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

  2. Toxicity profile

    Measured: Toxicity assessment on each chemotherapy cycle

  3. 1 year Survival and Overall Survival

    Measured: Probability of 1-year survival (%)

  4. Correlation of the molecular characteristics of the tumor with the clinical outcome

    Measured: Corralation after the end of chemotherapy

Timeline

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

  1. First posted19 Sep 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionNov 2008
  4. Study completionNov 2008

Why it stopped: Due to poor accrual

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
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00755534
Sponsor's protocol ID
CT/05.31
Status last verified
Feb 2013
First submitted
18 Sep 2008
Last updated
13 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan, Capecitabine and Cetuximab in people with Colorectal Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.

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 9 inclusion and 11 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 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Greece. 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: Due to poor accrual). 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?

Time To Progression (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 NCT00755534.

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 13 Feb 2013.

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