Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer

Rectal Cancer Clinical Trial

— XERT  

Official title:

Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00689702
• Other study ID #: EMR 62202-688
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 30, 2008
• Last updated: March 23, 2012
• Start date: February 2007
• Est. completion date: May 2013

Study information

• Verified date: March 2012
• Source: Institute of Oncology Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Agency for Medicinal Products - Ministry of HealthSlovenia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectable rectal cancers.

Description:

Preoperative radiotherapy and 5-FU based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.Capecitabine has the potential to replace 5-FU as standard agent. Cetuximab is a monoclonal antibody directed against EGFR. Both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.The trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage II and III rectal cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: May 2013
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18 to 80 if judged fit for surgery

• WHO performance status 0-1

• Histologically proven rectal adenocarcinoma located below the peritoneum

• T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI

• No distant metastases

• Adequate haematological, cardiac, liver and renal function

• Signed informed consent

• Appropriate measures for contraception for men and women, if applicable

Exclusion Criteria:

• Prior radio- and/or chemotherapy

• Others synchronous cancers

• History of other malignant disease

• Significant heart disease

• Known hypersensitivity to biological drugs

• Pregnant or lactating patient

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• cetuximab, capecitabine
Cetuximab 400mg/m2 in iv infusion as an initial dose on day 15, then a weekly dose of 250mg/m2 for 5 weeks during radiotherapy (days 22, 29, 36, 43, 50). Capecitabine: 1250 mg/m² bd for 14 days (1 cycle); 825mg/m2 bd over 5 weeks during radiotherapy. Radiotherapy: planned total dose of 45 Gy in 25 fractions using a four-field plan in 5 weeks.

Locations

Country	Name	City	State
Slovenia	Institute of Oncology	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

Grünwald V, Hidalgo M. Development of the epidermal growth factor receptor inhibitor Tarceva (OSI-774). Adv Exp Med Biol. 2003;532:235-46. Review. — View Citation

Kim JC, Kim TW, Kim JH, Yu CS, Kim HC, Chang HM, Ryu MH, Park JH, Ahn SD, Lee SW, Shin SS, Kim JS, Choi EK. Preoperative concurrent radiotherapy with capecitabine before total mesorectal excision in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):346-53. — View Citation

Robert F, Ezekiel MP, Spencer SA, Meredith RF, Bonner JA, Khazaeli MB, Saleh MN, Carey D, LoBuglio AF, Wheeler RH, Cooper MR, Waksal HW. Phase I study of anti--epidermal growth factor receptor antibody cetuximab in combination with radiation therapy in patients with advanced head and neck cancer. J Clin Oncol. 2001 Jul 1;19(13):3234-43. — View Citation

Velenik V, Anderluh F, Oblak I, Strojan P, Zakotnik B. Capecitabine as a radiosensitizing agent in neoadjuvant treatment of locally advanced resectable rectal cancer: prospective phase II trial. Croat Med J. 2006 Oct;47(5):693-700. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete pathological remission rate		at pathological examm of surgical speciment	No
Secondary	Rate of sphincter sparing surgical procedure Toxicity/safety		Toxicity/safety:during preoperative treatment, early and late postoperative follow up	Yes