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Trial record 23 of 436 for:    colon cancer AND Capecitabine

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

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ClinicalTrials.gov Identifier: NCT00227734
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : June 5, 2012
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date June 5, 2012
Study Start Date  ICMJE June 2004
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2007)
Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00227734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description

OBJECTIVES:

  • 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.

Secondary

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: capecitabine and oxaliplatin + cetuximab
    cetuximab
  • Drug: capecitabine and oxaliplatin
    capecitabine and oxaliplatin without cetuximab
Study Arms  ICMJE
  • Active Comparator: Arm I
    Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.
    Intervention: Drug: capecitabine and oxaliplatin
  • 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
    Intervention: Drug: capecitabine and oxaliplatin + cetuximab
Publications * Borner M, Koeberle D, Von Moos R, Saletti P, Rauch D, Hess V, Trojan A, Helbling D, Pestalozzi B, Caspar C, Ruhstaller T, Roth A, Kappeler A, Dietrich D, Lanz D, Mingrone W; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland. Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK. Ann Oncol. 2008 Jul;19(7):1288-92. doi: 10.1093/annonc/mdn058. Epub 2008 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2012)
74
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal

Renal

  • Creatinine clearance > 50 ml/min

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for advanced or metastatic cancer
  • At least 6 months since prior adjuvant chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00227734
Other Study ID Numbers  ICMJE SAKK 41/04
EU-20525
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Swiss Group for Clinical Cancer Research
Study Sponsor  ICMJE Swiss Group for Clinical Cancer Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Markus M. Borner, MD University Hospital Inselspital, Berne
Principal Investigator: Dieter Koeberle, MD Cantonal Hospital of St. Gallen
PRS Account Swiss Group for Clinical Cancer Research
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP