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AzTrials

Colorectal CancerPhase 2NCT00227734

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

A Phase 2 study testing capecitabine and oxaliplatin + cetuximab and capecitabine and oxaliplatin in people with Colorectal Cancer, run by Swiss Cancer Institute at 18 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
capecitabine and oxaliplatin + cetuximab and capecitabine and oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
18 sitesSwitzerland
Study dates
Jun 2004to Feb 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Switzerland18 sites

  • Kantonspital Aarau

    Aarau, 5001

  • Hirslanden Klinik Aarau

    Aarau, CH-5001

  • Praxis Dr. Streit

    Baden, 5404

  • Kantonsspital Baden

    Baden, CH-5404

  • Saint Claraspital AG

    Basel, CH-4016

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Inselspital Bern

    Bern, CH-3010

  • Kantonsspital Bruderholz

    Bruderholz, CH-4101

  • Spitaeler Chur AG

    Chur, CH-7000

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Kantonsspital

    Liestal, CH-4410

  • Ospedale Civico

    Lugano, CH-6900

  • Praxis Dr. Beretta

    Rheinfelden, 4310

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Regionalspital

    Thun, 3600

  • City Hospital Triemli

    Zurich, 8063

  • Stadtspital Waid

    Zurich, CH-8037

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
capecitabine and oxaliplatin + cetuximab, capecitabine and oxaliplatin
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capecitabine and oxaliplatin + cetuximabDrug

    cetuximab

  • capecitabine and oxaliplatinDrug

    capecitabine and oxaliplatin without cetuximab

Study groups in NCT00227734
Study groupRoleWhat they receive
Arm IActive comparatorPatients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.
Receives: Drug: capecitabine and oxaliplatin
Arm IIActive comparatorPatients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8
Receives: Drug: capecitabine and oxaliplatin + cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

  1. Clinical benefit (CR, PR, and stable disease [SD]) measured at 18 weeks after randomization

  2. Time to progression

  3. Overall survival

  4. Time to treatment failure measured after completion of study treatment

  5. Adverse drug reactions measured after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionOct 2005
  4. Study completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00227734
Sponsor's protocol ID
SAKK 41/04
Other IDs
EU-20525
Status last verified
Jun 2012
First submitted
26 Sep 2005
Last updated
5 Jun 2012
Results posted
No
Data monitoring committee
Yes

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):1288-1292. doi: 10.1093/annonc/mdn058. Epub 2008 Mar 17.

    PubMed 18349029

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine and oxaliplatin + cetuximab and capecitabine and oxaliplatin in people with Colorectal Cancer, run by Swiss Cancer Institute at 18 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00227734, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.

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