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Trial record 18 of 435 for:    colon cancer AND Capecitabine AND colon cancer

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

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Capecitabine Drug: irinotecan hydrochloride Drug: oxaliplatin Phase 1 Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oxaliplatin, Irinotecan, and Capecitabine as a Combination Regimen for First-Line Treatment of Advanced or Metastatic Colorectal Cancer
Study Start Date : May 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A
Oxaliplatin, Irinotecan, and Capecitabine
Drug: Capecitabine
capecitabine

Drug: irinotecan hydrochloride
irinotecan hydrochloride

Drug: oxaliplatin
oxaliplatin




Primary Outcome Measures :
  1. 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)

  2. Efficacy of Oxaliplatin, Irinotecan, and Capecitabine [ Time Frame: 2 months ]
    Determine the efficacy of this regimen in these patients (Phase II)


Secondary Outcome Measures :
  1. Objective response (CR or PR) as measured after completion of study treatment [ Time Frame: 2 months ]
  2. Adverse events as measured after completion of study treatment [ Time Frame: 2 months ]
  3. Time to progression [ Time Frame: life-long ]
  4. Time to treatment failure as measured after completion of study treatment [ Time Frame: life-long ]
  5. Overall survival [ Time Frame: life-long ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217711


Locations
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Switzerland
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Hirslanden Klinik Aarau
Lausanne, Switzerland, CH-1011
City Hospital Triemli
Zurich, Switzerland, CH-8063
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Razvan Popescu, MD Centre Hospitalier Universitaire Vaudois

Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00217711     History of Changes
Other Study ID Numbers: SAKK 41/03
EU-20524
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012
Keywords provided by Swiss Group for Clinical Cancer Research:
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors