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Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00012389
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 3, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date December 19, 2013
Study Start Date  ICMJE December 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
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 Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Official Title  ICMJE A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer.

Detailed Description

OBJECTIVES:

  • Compare the overall survival of patients with metastatic colorectal cancer treated with irinotecan with or without oxaliplatin.
  • Compare the response rate, time to tumor-related worsening of symptoms, time to disease progression, onset and duration of responses, and duration of disease stabilization in these patients treated with these regimens.
  • Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive irinotecan IV over 90 minutes on day 1.
  • Arm II: Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over 30 minutes on day 1.

Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study within 18 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: irinotecan hydrochloride
  • Drug: oxaliplatin
Study Arms  ICMJE Not Provided
Publications * Haller DG, Rothenberg ML, Wong AO, Koralewski PM, Miller WH Jr, Bodoky G, Habboubi N, Garay C, Olivatto LO. Oxaliplatin plus irinotecan compared with irinotecan alone as second-line treatment after single-agent fluoropyrimidine therapy for metastatic colorectal carcinoma. J Clin Oncol. 2008 Oct 1;26(28):4544-50. doi: 10.1200/JCO.2008.17.1249.

*   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
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
  • Metastatic or recurrent disease that is not amenable to potentially curative treatment
  • Progressive or recurrent disease during or after 1, and only 1, regimen of fluorouracil with or without leucovorin calcium or during or within 6 months after adjuvant chemotherapy with fluorouracil and leucovorin calcium

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No unstable angina
  • No New York Heart Association class III or IV congestive heart failure
  • No serious cardiac arrhythmia
  • No history of cardiac toxicity from fluorouracil/leucovorin calcium
  • No myocardial infarction within past 6 months

Pulmonary:

  • No interstitial pneumonia or extensive and symptomatic fibrosis of the lung

Other:

  • No uncontrolled predisposing colonic or small bowel disorder
  • No prior chronic enteropathy, chronic diarrhea, or unresolved bowel obstruction/subobstruction
  • No diabetes
  • No active infection
  • No known current peripheral neuropathy
  • No concurrent active cancer except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No intolerance of appropriate antiemetics
  • No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • No prior irinotecan or oxaliplatin
  • No other prior chemotherapy agents except fluorouracil with or without leucovorin calcium as first-line therapy for metastatic disease or in the adjuvant setting

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy to non-target lesions allowed
  • No prior radiotherapy to target lesions unless disease progression is documented within the radiation port
  • At least 3 weeks since prior radiotherapy

Surgery:

  • At least 4 weeks since prior major surgical procedure and recovered
  • Prior surgery for primary tumor or metastasis allowed

Other:

  • At least 30 days since prior investigational drug
  • No concurrent investigational agents
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 United States,   Brazil,   Canada,   Czech Republic,   Hungary,   Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00012389
Other Study ID Numbers  ICMJE CDR0000068524
SANOFI-EFC4585
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Daniel G. Haller, MD Abramson Cancer Center of the University of Pennsylvania
PRS Account National Cancer Institute (NCI)
Verification Date October 2002

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