NCT00689702

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

2.2 years

First QC Date

May 30, 2008

Last Update Submit

March 23, 2012

Conditions

Rectal Cancer

Keywords

cetuximabcapecitabineradiotherapyrectal cancer

Outcome Measures

Primary Outcomes (1)

  • Complete pathological remission rate

    at pathological examm of surgical speciment

Secondary Outcomes (1)

  • Rate of sphincter sparing surgical procedure Toxicity/safety

    Toxicity/safety:during preoperative treatment, early and late postoperative follow up

Interventions

cetuximab, capecitabineDRUG

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.

Also known as: Erbitux, Xeloda

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology

Ljubljana, Slovenia, 1000, Slovenia

Location

Related Publications (4)

  • 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.

    PMID: 15913913BACKGROUND

  • 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.

    PMID: 12908562BACKGROUND

  • 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.

    PMID: 17042060BACKGROUND

  • 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.

    PMID: 11432891BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

CetuximabCapecitabine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Vaneja Velenik, PhD, MD

    Institute of Oncology, Ljubljana, Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 4, 2008

Study Start

February 1, 2007

Primary Completion

April 1, 2009

Study Completion

May 1, 2013

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

SL(1)