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

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ClinicalTrials.gov Identifier: NCT00217711
Recruitment Status : Completed
First Posted : September 22, 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 20, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date June 5, 2012
Study Start Date  ICMJE May 2005
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2012)
  • capecitabine + oxaliplatin + irinotecan dose finding [ Time Frame: 30 days ]
    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)
  • Efficacy of Oxaliplatin, Irinotecan, and Capecitabine [ Time Frame: 2 months ]
    Determine the efficacy of this regimen in these patients (Phase II)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00217711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2012)
  • Objective response (CR or PR) as measured after completion of study treatment [ Time Frame: 2 months ]
  • Adverse events as measured after completion of study treatment [ Time Frame: 2 months ]
  • Time to progression [ Time Frame: life-long ]
  • Time to treatment failure as measured after completion of study treatment [ Time Frame: life-long ]
  • Overall survival [ Time Frame: life-long ]
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 Oxaliplatin, Irinotecan, and Capecitabine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Official Title  ICMJE Oxaliplatin, Irinotecan, and Capecitabine as a Combination Regimen for First-Line Treatment of Advanced or Metastatic Colorectal Cancer
Brief 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.

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.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Capecitabine
    capecitabine
  • Drug: irinotecan hydrochloride
    irinotecan hydrochloride
  • Drug: oxaliplatin
    oxaliplatin
Study Arms  ICMJE Active Comparator: Arm A
Oxaliplatin, Irinotecan, and Capecitabine
Interventions:
  • Drug: Capecitabine
  • Drug: irinotecan hydrochloride
  • Drug: oxaliplatin
Publications * von Moos R, Roth A, Ruhstaller T, Widmer L, Uhlmann C, Cathomas R, Köberle 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.

*   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 2, 2012)
23
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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 NCT00217711
Other Study ID Numbers  ICMJE SAKK 41/03
EU-20524
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: Razvan Popescu, MD Centre Hospitalier Universitaire Vaudois
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