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

Sponsor
University College, London
Study ID
NCT00972881
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • cetuximab — BIOLOGICAL
  • capecitabine — DRUG
  • irinotecan hydrochloride — DRUG
  • neoadjuvant therapy — PROCEDURE
  • therapeutic conventional surgery — PROCEDURE
  • radiation therapy — RADIATION

Study Details

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.

Key Dates

Start date
Apr 30, 2009
Status verified
Dec 2014
Primary completion
Dec 31, 2011
Completion
Dec 31, 2016

Study Design

Enrollment
82 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Histologically confirmed R0 resection rate [ Time Frame: Week 14 (6 weeks after treatment complete) ]

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