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

Phase 2
70 Years
Not Enrolling
Metastatic Colorectal Cancer

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Trial Information

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

- This open-label, non-controlled, multicentre, phase II study will recruit 53 elderly
patients with diagnosis of metastatic colorectal cancer.

- All patients will receive 4 cycles of treatment with cetuximab plus XELOX followed by
cetuximab plus capecitabine as maintenance therapy until progression of disease,
occurrence of unacceptable toxicity to the study drugs, or withdrawal of consent by the

- The planned duration of a cycle is 3 weeks.

- Cetuximab therapy will not be delayed for chemotherapy-related toxicity and vice versa.
If patients benefit from combination therapy, but develop unacceptable intolerance to
oxaliplatin and/or capecitabine, cetuximab may be continued in combination with the
other chemotherapy drug and/or as a single agent. In case of cetuximab intolerance,
patients should continue with chemotherapy treatment until progression disease.

- Evaluations:

- Efficacy data (response rate, progression-free survival, duration of response and
survival) and safety data will be collected. The investigators will assess
responses to treatment.

- When the treatment is stopped either because of disease progression or occurrence
of unacceptable toxicity, the patients will enter a follow-up period where the
progression-free survival, the subsequent lines of treatment and the survival data
will be collected every 12 weeks.

Inclusion Criteria:

- 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,

Exclusion Criteria:

- Documented or suspected cerebral and/or leptomeningeal metastases.

- Surgery (excluding biopsy for diagnosis) and/or radiotherapy during the 4 weeks prior
to inclusion in the study.

- Chronic, concomitant systemic immunotherapy, chemotherapy, or hormonal treatment for

- 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

- 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

- Dependence in one or more activities of daily life according to the Katz
Activity of Daily Living (ADL) scale.

- 3 or more comorbid entities based on evaluation of the presence of the following
processes: congestive heart failure; valvular heart disease; coronary artery
disease; obstructive or restrictive chronic pulmonary disease; cerebrovascular
disease; peripheral neuropathies; chronic renal failure; hypertension; diabetes;
concomitant neoplasms; collagen vascular diseases; and incapacitating arthritis.

- Presence of geriatric syndromes: moderate-severe dementia; delirium in situation
of stress (urinary or respiratory infection, angina or drugs); moderate-severe
depression that interferes with usual activity of patient; frequent falls (3 or
more per month); lack of care (Who could help him or her in the event of an
emergency?); urinary incontinence in the absence of stress, infection, diuretics
or prostatic hyperplasia; fecal incontinence in the absence of diarrhea or
laxatives; osteoporotic fractures of long bones or vertebral crush.

Type of Study:


Study Design:

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

Outcome Measure:

Confirmed objective response rate

Outcome Time Frame:


Safety Issue:


Principal Investigator

Javier Sastre

Investigator Role:

Study Chair

Investigator Affiliation:

H. Clinico San Carlos. Madrid. Spain


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

November 2007

Completion Date:

April 2009

Related Keywords:

  • Metastatic Colorectal Cancer
  • metastatic colorectal cancer
  • elderly patients
  • cetuximab, oxaliplatin, capecitabine
  • Colorectal Neoplasms