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AzTrials

Colorectal CancerPhase 1/2NCT00217711

Oxaliplatin, Irinotecan, and Capecitabine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

A Phase 1/2 study testing Capecitabine, irinotecan hydrochloride and oxaliplatin in people with Colorectal Cancer, run by Swiss Cancer Institute at 4 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 oxaliplatin, irinotecan, and capecitabine, 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 to 70 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Capecitabine, irinotecan hydrochloride and oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
4 sitesSwitzerland
Study dates
May 2005to Oct 2011
Phase
Phase 1/2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer
  • Measurable disease (phase II only)
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI
  • No presence or history of CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 to 70

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 ≤ 1.25 times upper limit of normal (ULN) (1.5 times ULN if liver metastases are present)
  • AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)

Renal

  • Creatinine clearance > 60 mL/min

Cardiovascular

  • No New York Heart Association class III-IV congestive heart failure
  • No symptomatic coronary artery disease
  • No uncontrolled cardiac arrhythmia
  • No myocardial infarction within the past year
  • No other clinically significant cardiac disease

Immunologic

  • No active autoimmune disease
  • No uncontrolled infection
  • No prior severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil
  • No known hypersensitivity to any component of study drugs

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Patients must use effective contraception during and for 1 year after study participation
  • No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
  • No peripheral neuropathy > grade 1 of any origin (e.g., alcohol or diabetes)
  • No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication
  • No psychiatric disability that would preclude study compliance
  • No uncontrolled diabetes
  • No other serious underlying medical condition that would preclude study participation
  • No known dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic hematopoietic growth factors

Chemotherapy

  • More than 6 months since prior adjuvant fluoropyrimidine chemotherapy
  • No other prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy
  • Concurrent radiotherapy of a single painful lesion allowed

Surgery

  • Not specified

Other

  • More than 30 days since prior clinical trial participation
  • No other concurrent experimental drugs
  • No other concurrent anticancer therapy
  • No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Hirslanden Klinik Aarau

    Lausanne, CH-1011

  • City Hospital Triemli

    Zurich, CH-8063

Other trials in Switzerland

About this study

Official title: Oxaliplatin, Irinotecan, and Capecitabine as a Combination Regimen for First-Line Treatment of Advanced or Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, 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.

PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer. (Phase I)
  • Determine the efficacy of this regimen in these patients. (Phase II)

Secondary

  • Determine the tolerability of this regimen in these patients. (Phase II)

OUTLINE: This is a multicenter, phase I dose-escalation study of capecitabine followed by a phase II study.

  • Phase I: Patients receive oxaliplatin IV over 2 hours on days 1 and 15, irinotecan IV over 1 hour on days 8 and 22, and oral capecitabine twice daily on days 1-29. Treatment repeats every 5 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive capecitabine at the MTD and irinotecan and oxaliplatin as in phase I.

After completion of study treatment, patients are followed every 2 months for 1 year and then every 4 months thereafter.

PROJECTED ACCRUAL: A total of 23-32 patients (3-12 for the phase I portion and 20 for the phase II portion) will be accrued for this study within 2.75 years

Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV 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.

Study groups in NCT00217711
Study groupRoleWhat they receive
Arm AActive comparatorOxaliplatin, Irinotecan, and Capecitabine
Receives: Drug: Capecitabine; Drug: irinotecan hydrochloride; Drug: oxaliplatin

What is being measured

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

  1. capecitabine + oxaliplatin + irinotecan dose finding

    Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer. (Phase I)

    Measured: 30 days

  2. Efficacy of Oxaliplatin, Irinotecan, and Capecitabine

    Determine the efficacy of this regimen in these patients (Phase II)

    Measured: 2 months

Secondary outcomes (5)

  1. Objective response (CR or PR) as measured after completion of study treatment

    Measured: 2 months

  2. Adverse events as measured after completion of study treatment

    Measured: 2 months

  3. Time to progression

    Measured: life-long

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

    Measured: life-long

  5. Overall survival

    Measured: life-long

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionAug 2007
  4. Study completionOct 2011

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217711
Sponsor's protocol ID
SAKK 41/03
Other IDs
EU-20524
Status last verified
Jun 2012
First submitted
20 Sep 2005
Last updated
5 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • von Moos R, Roth A, Ruhstaller T, Widmer L, Uhlmann C, Cathomas R, Koberle D, Simcock M, Lanz D, Popescu R. Oxaliplatin, irinotecan and capecitabine (OCX) for first-line treatment of advanced/metastatic colorectal cancer: a phase I trial (SAKK 41/03). Onkologie. 2010;33(6):295-9. doi: 10.1159/000313598. Epub 2010 May 14.

    PubMed 20523092

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Capecitabine, irinotecan hydrochloride and oxaliplatin in people with Colorectal Cancer, run by Swiss Cancer Institute at 4 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 4 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

capecitabine + oxaliplatin + irinotecan dose finding (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT00217711, 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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