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Capecitabine and Oxaliplatin Alone or in Combination With Cetuximab as First-Line Treatment for Metastatic EGFR-Positive Colorectal Cancer, A Randomized Multicenter Phase II Trial

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Capecitabine and Oxaliplatin Alone or in Combination With Cetuximab as First-Line Treatment for Metastatic EGFR-Positive Colorectal Cancer, A Randomized Multicenter Phase II Trial


- Compare the efficacy of capecitabine and oxaliplatin with vs without cetuximab in
patients with epidermal growth factor receptor-positive metastatic unresectable
colorectal cancer.

- Compare the objective response (complete and partial response) in patients treated with
these regimens.


- Compare the safety of these regimens in these patients.

- Compare the clinical benefit (complete response, partial response, or stable disease
for at least 18 weeks) in patients treated with these regimens.

- Compare overall survival, time to progression, and time to treatment failure in
patients treated with these regimens.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
performance status (0 vs 1), type of metastases (synchronous vs metachronous), prior
adjuvant chemotherapy (yes vs no), and participating center. Patients are randomized to 1 of
2 treatment arms.

- Arm I: Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV
over 2 hours on day 1.

- Arm II: Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over
1-2 hours on days 1 and 8.

In both arms, courses repeat every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients will be followed every 3 months for 1 year and
then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this
study within 1.5 years.

Inclusion Criteria


- Histologically or cytologically confirmed metastatic colorectal cancer

- Unresectable disease

- Primary tumor or metastases must be epidermal growth factor receptor-positive by

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by CT scan

- Measurable lesion must not be in a previously irradiated area

- No prior or current CNS metastases



- 18 and over

Performance status

- WHO 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin normal


- Creatinine clearance > 50 ml/min


- No New York Heart Association class III or IV congestive heart failure

- No symptomatic coronary artery disease

- No uncontrolled cardiac arrhythmia

- No myocardial infarction within the past 12 months

- No other significant cardiac disease


- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 12 months after
study participation

- Negative pregnancy test

- No peripheral neuropathy of any origin > grade 1 (e.g., alcohol or diabetes)

- No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or
absorption of oral medication

- No severe reaction attributed to fluoropyrimidine therapy

- No known hypersensitivity to fluorouracil or any other component of the trial drugs

- No known dihydropyrimidine dehydrogenase deficiency

- No other medical condition (e.g., uncontrolled diabetes or active autoimmune
disease), geographical situation, or psychiatric disorder that would preclude study

- No other malignancy within the past 5 years except adequately treated carcinoma in
situ of the cervix or localized nonmelanoma skin cancer


Biologic therapy

- Not specified


- No prior chemotherapy for advanced or metastatic cancer

- At least 6 months since prior adjuvant chemotherapy

Endocrine therapy

- Not specified


- Not specified


- Not specified


- At least 30 days since prior experimental drugs

- No other concurrent experimental drugs

- No concurrent drugs that are contraindicated for use with the trial drugs

- No other concurrent anticancer therapy

- No concurrent sorivudine or any of its chemically-related analogues (e.g.,

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment

Safety Issue:


Principal Investigator

Markus M. Borner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Inselspital, Berne


Switzerland: Swissmedic

Study ID:

SAKK 41/04



Start Date:

June 2004

Completion Date:

February 2006

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms