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Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

This study has been completed.
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research Identifier:
First received: September 26, 2005
Last updated: June 4, 2012
Last verified: June 2012

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine and oxaliplatin together with cetuximab is more effective than capecitabine and oxaliplatin in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying how well giving capecitabine and oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine and oxaliplatin + cetuximab
Drug: capecitabine and oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment

Secondary Outcome Measures:
  • Clinical benefit (CR, PR, and stable disease [SD]) measured at 18 weeks after randomization
  • Time to progression
  • Overall survival
  • Time to treatment failure measured after completion of study treatment
  • Adverse drug reactions measured after completion of study treatment

Enrollment: 74
Study Start Date: June 2004
Study Completion Date: February 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.
Drug: capecitabine and oxaliplatin
capecitabine and oxaliplatin without cetuximab
Active Comparator: Arm II
Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8
Drug: capecitabine and oxaliplatin + cetuximab

Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed metastatic colorectal cancer

    • Unresectable disease
    • Primary tumor or metastases must be epidermal growth factor receptor-positive by immunohistochemistry
  • 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 compliance
  • 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., lamivudine)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00227734

Kantonspital Aarau
Aarau, Switzerland, 5001
Hirslanden Klinik Aarau
Aarau, Switzerland, CH-5001
Praxis Dr. Streit
Baden, Switzerland, 5404
Kantonsspital Baden
Baden, Switzerland, CH-5404
Saint Claraspital AG
Basel, Switzerland, CH-4016
Basel, Switzerland, CH-4031
Inselspital Bern
Bern, Switzerland, CH-3010
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
Spitaeler Chur AG
Chur, Switzerland, CH-7000
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Liestal, Switzerland, CH-4410
Ospedale Civico
Lugano, Switzerland, CH-6900
Praxis Dr. Beretta
Rheinfelden, Switzerland, 4310
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Thun, Switzerland, 3600
City Hospital Triemli
Zurich, Switzerland, 8063
Stadtspital Waid
Zurich, Switzerland, CH-8037
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Markus M. Borner, MD University Hospital Inselspital, Berne
Principal Investigator: Dieter Koeberle, MD Cantonal Hospital of St. Gallen
  More Information

Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00227734     History of Changes
Other Study ID Numbers: SAKK 41/04
Study First Received: September 26, 2005
Last Updated: June 4, 2012

Keywords provided by Swiss Group for Clinical Cancer Research:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017