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CompletedNCT00972881EXCITEUpdated Oct 25, 2017

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

A Phase 1/2 interventional study of cetuximab and capecitabine in Rectal Cancer, sponsored by University College, London. Completed at 5 sites in United Kingdom. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by University College, London · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
82
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Rectal Cancer

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Keywords

  • adenocarcinoma of the rectum
  • Locally advanced rectal cancer
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 82 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
82 participants (actual)

Interventions

  • Biologicalcetuximab
  • Drugcapecitabine
  • Drugirinotecan hydrochloride
  • Procedureneoadjuvant therapy
  • Proceduretherapeutic conventional surgery
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Histologically confirmed R0 resection rate

    Time frame: Week 14 (6 weeks after treatment complete)

Secondary outcomes

  1. Radiotherapy compliance

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

    Time frame: 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.

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

  3. Pathological complete response

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

  4. Post-operative morbidity

    Time frame: Week 14

  5. Long-term morbidity

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

  6. Disease-free survival

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

  7. Local failure-free survival

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

07

Study locations

5 sites
  • Yorkshire Regional Clinical Trials & Research Unit
    Leeds, England LS16 6QB, United Kingdom
  • Christie Hospital
    Manchester, England M20 4BX, United Kingdom
  • Clatterbridge Centre for Oncology
    Merseyside, England CH63 4JY, United Kingdom
  • Rosemere Cancer Centre at Royal Preston Hospital
    Preston, England PR2 9HT, United Kingdom
  • Cancer Research UK and University College London Cancer Trials Centre
    Rhyl, Denbighshire, Wales LL 18 5UJ, United Kingdom
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00972881
Lead sponsor
University College, London
Responsible party
Sponsor
First posted
Sep 9, 2009
Start date
Apr 2009
Primary completion
Dec 2011
Completion
Dec 31, 2016
Last update
Oct 25, 2017

Study contacts

Simon Gollins, MD
principal investigator · Glan Clwyd Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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