Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer (EXCITE)
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.
Drug: irinotecan hydrochloride
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Histologically confirmed R0 resection rate [ Time Frame: Week 14 (6 weeks after treatment complete) ] [ Designated as safety issue: No ]
- Radiotherapy compliance [ Time Frame: Weeks 2, 3, 4, 5 & 6 ] [ Designated as safety issue: No ]Radiotherapy treatment and dosage is captured on weekly CRFs from week 2-6
- Grade 3 or 4 toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Baseline, week 1- 10, week 12 & 14 then at 6, 12, 24 & 36 months follow up ] [ Designated as safety issue: Yes ]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.
- Pathological complete response [ Time Frame: Week 14 (surgery conducted 6 weeks from end of treatment) ] [ Designated as safety issue: No ]
- Post-operative morbidity [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
- Long-term morbidity [ Time Frame: Week 14, then at 6, 12, 24 & 36 months follow up ] [ Designated as safety issue: No ]
- Disease-free survival [ Time Frame: Baseline, week 1- 10, week 12, 14 & then at 6, 12, 24 & 36 months follow up ] [ Designated as safety issue: No ]
- Local failure-free survival [ Time Frame: Baseline, weeks 1- 10, weeks 12 & 14 then at 6, 12, 24 & 36 months follow up ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972881
|Yorkshire Regional Clinical Trials & Research Unit|
|Leeds, England, United Kingdom, LS16 6QB|
|Manchester, England, United Kingdom, M20 4BX|
|Clatterbridge Centre for Oncology|
|Merseyside, England, United Kingdom, CH63 4JY|
|Rosemere Cancer Centre at Royal Preston Hospital|
|Preston, England, United Kingdom, PR2 9HT|
|Cancer Research UK and University College London Cancer Trials Centre|
|Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ|
|Principal Investigator:||Simon Gollins, MD||Glan Clwyd Hospital|