Clinical trial NCT00689702: Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer
Official title: Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: cetuximab
capecitabine
radiotherapy
rectal cancer
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete pathological remission rate
timeFrame: at pathological examm of surgical speciment
Secondary outcomes:
measure: Rate of sphincter sparing surgical procedure Toxicity/safety
timeFrame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institute of Oncology
Study officials:
affiliation: Institute of Oncology, Ljubljana, Slovenia
name: Vaneja Velenik, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.ijrobp.2005.02.046.
citation: Grunwald V, Hidalgo M. Development of the epidermal growth factor receptor inhibitor Tarceva (OSI-774). Adv Exp Med Biol. 2003;532:235-46. doi: 10.1007/978-1-4615-0081-0_19.
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.
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. doi: 10.1200/JCO.2001.19.13.3234.