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Rectal CancerPhase 1/2EXCITENCT00972881

Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

A Phase 1/2 study testing cetuximab, capecitabine and irinotecan hydrochloride in people with Rectal Cancer, run by University College, London at 5 sites in United Kingdom.

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

RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Rectal Cancer
What is being tested?
cetuximab, capecitabine and irinotecan hydrochloride
Type of treatment
Surgery or procedure
How many people
82 participants
Where
5 sitesUnited Kingdom
Study dates
Apr 2009to 31 Dec 2016
Phase
Phase 1/2
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 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the rectum
  • MRI-defined locally advanced disease, as defined by 1 of the following:
  • Mesorectal fascia involvement
  • Mesorectal fascia threatened (tumor ≤ 1 mm from mesorectal fascia)
  • Any T3 tumor < 5 cm from anal verge
  • No evidence of metastatic disease

PATIENT CHARACTERISTICS:

  • ECOG or WHO performance status 0-1
  • ANC ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Serum bilirubin < 1.25 times upper limit of normal (ULN)
  • Serum transaminase(s) < 3 times ULN
  • Serum alkaline phosphatase < 5 times ULN
  • Estimated glomerular filtration rate > 50 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Fit to receive all study treatments
  • Able to comply with oral medication
  • No comorbidity or coagulation problem that would deem the patient unsuitable for surgery
  • No pre-existing condition that would preclude radiotherapy (e.g., fistulas, severe ulcerative colitis [particularly patients currently taking sulfasalazine], Crohn's disease, prior adhesions)
  • No current or impending rectal obstruction (unless a defunctioning stoma is present) or metallic colonic rectal stent in situ
  • No significant small bowel delineated within the radiotherapy fields
  • No pelvic sepsis
  • No gastrointestinal disorder that would interfere with oral therapy or oral bioavailability
  • No uncontrolled cardiac, respiratory, or other disease that would preclude study therapy or informed consent
  • No serious medical or psychiatric disorder that would preclude study therapy or informed consent
  • No known dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior radiotherapy to the pelvis
  • No concurrent participation in other studies, except genetic studies (e.g., NSCCG-National Study of Colorectal Cancer Genetics)
  • No concurrent St. John wort
  • No other concurrent cytotoxic treatment or radiotherapy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • Yorkshire Regional Clinical Trials & Research Unit

    Leeds, England, LS16 6QB

  • Christie Hospital

    Manchester, England, M20 4BX

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • Rosemere Cancer Centre at Royal Preston Hospital

    Preston, England, PR2 9HT

  • Cancer Research UK and University College London Cancer Trials Centre

    Rhyl, Denbighshire, Wales, LL 18 5UJ

Other trials in United Kingdom

About this study

Official title: EXCITE: Erbitux, Xeloda, Campto, Irradiation Then Excision for Locally Advanced Rectal Cancer (North West Clinical Oncology Group-04 on Behalf of the NCRI Rectal Cancer Subgroup)

RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy, cetuximab, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I/II trial is studying the side effects of giving capecitabine and irinotecan hydrochloride together with cetuximab and radiation therapy and to see how well it works in treating patients undergoing surgery for locally advanced rectal cancer.

Read the detailed description

OBJECTIVES:

  • To assess the downstaging effectiveness and tolerability of neoadjuvant chemoradiotherapy comprising capecitabine, irinotecan hydrochloride, cetuximab, and radiotherapy in patients with locally advanced rectal cancer.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-6 and irinotecan hydrochloride IV over 1 hour once weekly in weeks 2-5. Patients also undergo pelvic radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 in weeks 2-6.

Patients undergo surgery 8 weeks after completion of chemoradiotherapy.

After completion of study treatment, patients are followed up at 6, 12, 24, and 36 months.

Peer Reviewed and Funded or Endorsed by Cancer Research United Kindom (UK).

Conditions
Rectal Cancer
Keywords
adenocarcinoma of the rectum, Locally advanced rectal cancer
Medical subject headings
Rectal Neoplasms

What participants receive

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

What is being measured

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

  1. Histologically confirmed R0 resection rate

    Measured: Week 14 (6 weeks after treatment complete)

Secondary outcomes (7)

  1. Radiotherapy compliance

    Radiotherapy treatment and dosage is captured on weekly CRFs from week 2-6

    Measured: Weeks 2, 3, 4, 5 & 6

  2. Grade 3 or 4 toxicity as assessed by NCI CTCAE v3.0

    Adverse events are recorded weekly on CRFs from week 1 of treatment until 4 weeks post treatment, then at 1 month post surgery and specified time points during long term follow up at 6, 12, 24 \& 36 month intervals.

    Measured: Baseline, week 1- 10, week 12 & 14 then at 6, 12, 24 & 36 months follow up

  3. Pathological complete response

    Measured: Week 14 (surgery conducted 6 weeks from end of treatment)

  4. Post-operative morbidity

    Measured: Week 14

  5. Long-term morbidity

    Measured: Week 14, then at 6, 12, 24 & 36 months follow up

  6. Disease-free survival

    Measured: Baseline, week 1- 10, week 12, 14 & then at 6, 12, 24 & 36 months follow up

  7. Local failure-free survival

    Measured: Baseline, weeks 1- 10, weeks 12 & 14 then at 6, 12, 24 & 36 months follow up

Timeline

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

  1. First posted9 Sep 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionDec 2011
  4. Study completion31 Dec 2016

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00972881
Sponsor's protocol ID
CDR0000648171
Other IDs
CRUK-UCL-EXCITE, EUDRACT-2007-006701-25, EU-20964
Acronym
EXCITE
Status last verified
Dec 2014
First submitted
5 Sep 2009
Last updated
25 Oct 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cetuximab, capecitabine and irinotecan hydrochloride in people with Rectal Cancer, run by University College, London at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Histologically confirmed R0 resection rate (time frame: Week 14 (6 weeks after treatment complete)). 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 NCT00972881.

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 25 Oct 2017.

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