Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With XELOX for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.

NCT00531115 | Terminated Phase 2

• 2 other identifiers: TTD-06-05EudraCT Nº: 2006-007062-11
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with cetuximab plus capecitabine as first line treatment in elderly patients with metastatic colorectal cancer

Conditions

Metastatic Colorectal Cancer

Keywords

metastatic colorectal cancer; elderly patients; cetuximab, oxaliplatin, capecitabine

Outcome Measures

Primary Outcomes (1)

• Confirmed objective response rate

  2007-2009

Secondary Outcomes (2)

• Disease control, Time to progression, progression-free survival,Time to treatment failure,Determine time to onset of response, Duration of response, Overall survival, To determine biologic prognostic factors

  2007-2009

• Treatment safety

  2007-2009

Study Arms (1)

1

EXPERIMENTAL

Drug: cetuximab 5mg/ml

Interventions

cetuximab 5mg/ml DRUG

Weekly administration of Cetuximab (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes) Oxaliplatin. 130 mg/m2 every three weeks. on day 1 for 4 cycles Capecitabine. 1000 mg/m2 twice daily (2.000 mg/m2 total daily dose) or 750 mg/m2 if Cl Cr=30-50 ml/min (1500 mg/m2 total daily dose) for two weeks (on days 1 to 14) followed by one week of rest (on days 15 to 21). The patients will receive 4 cycles of cetuximab plus combination chemotherapy administered every 3 weeks in order to achieve a noticeable response. Then, oxaliplatin treatment will be stopped after a maximum of 4 infusions to prevent appearance of neuropathy and then followed by capecitabine 2 weeks out of 3, and cetuximab weekly as maintenance treatment.

1

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Signed written informed consent before any study related activities are carried out
• Men and women \>= 70 years.
• Histologically confirmed diagnosis of CRC.
• Non-resectable and/or non-operable metastatic colorectal carcinoma.
• Presence of at least one lesion by two-dimensional measurement; index lesions should not be in a region with previous irradiation.
• Availability of tumor tissue for immunohistochemical analysis
• Karnofsky functional status \>= 80% at the time of enrollment in the study.
• Life expectancy greater than 3 months.
• Patients will not have received chemotherapy for advanced or metastatic disease. Patients with the following characteristics will be included: 1. Recurrence after neoadjuvant and/or adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free interval \> 12 months following conclusion of treatment. 2. Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment. 3. De novo diagnosis of disease.
• Proper hematological, renal and hepatic function,

You may not qualify if:

• Documented or suspected cerebral and/or leptomeningeal metastases.
• Chronic, concomitant systemic immunotherapy, chemotherapy, or hormonal treatment for cancer.
• Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
• Participation in another clinical trial with medication in the past 30 days
• Prior participation in a study in which treatment with cetuximab may be assigned (whether or not treatment with cetuximab is received).
• Prior malignant tumor in the past 5 years, except for history of adequately treated basal cell skin cancer or pre-invasive cervical cancer .
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome or history of inflammatory intestinal disease, acute or subacute intestinal occlusion or other disease which could alter drug absorption.
• Evidence of grade 3 or 4 allergic reaction to any treatment components or other fluoropyrimidines.
• Clinically relevant peripheral neuropathy.
• Clinically significant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of decompensation of heart failure or arrhythmia.
• Serious active infections (requiring intravenous antibiotics), including active tuberculosis and diagnosed HIV.
• Known abuse of alcohol/drugs.
• Legal incapacity or limited legal capacity.
• Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent.
• Patients catalogued as delicate or "frail" for compliance with any of the following criteria

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, 28046, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Javier Sastre

  H. Clinico San Carlos. Madrid. Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

ES (1)