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Trial record 22 of 54 for:    colon cancer | ( Map: Mississippi, United States )

Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00062426
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : November 6, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE June 5, 2003
First Posted Date  ICMJE June 6, 2003
Last Update Posted Date November 6, 2013
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00062426 on ClinicalTrials.gov Archive Site
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 Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
Official Title  ICMJE A Randomized, Prospective Study Comparing Three Regimens Of Eloxatin ™ Plus Fluoropyrimidine For Evaluation Of Safety And Tolerability In First Line Treatment Of Patients With Advanced Colorectal Cancer (Tree Study)
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different combinations may kill more tumor cells. Monoclonal antibodies, such as bevacizumab (Avastin™), can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known which regimen works better in treating advanced colorectal cancer.

PURPOSE: This randomized phase III trial is to see if oxaliplatin and bevacizumab work better when combined with either fluorouracil and leucovorin or capecitabine in treating patients who have metastatic or recurrent colorectal cancer.

Detailed Description

OBJECTIVES:

  • Compare the incidence of grade 3 and 4 toxic effects occurring within the first 12 weeks of treatment with 2 different schedules of oxaliplatin, bevacizumab (Avastin™), leucovorin calcium, and fluorouracil or with oxaliplatin, Avastin™, and capecitabine in patients with advanced colorectal cancer.
  • Compare the overall response rate, progression-free survival, and time to treatment failure in patients treated with these regimens.
  • Compare the composite toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive bevacizumab (Avastin™) IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil (5-FU) IV over 46 hours beginning on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium IV over 10 minutes and 5-FU IV over 3 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 3 months for at least 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 375 patients (125 per treatment arm) will be accrued for this study.

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
  • Biological: bevacizumab
  • Drug: capecitabine
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Drug: oxaliplatin
Study Arms  ICMJE Not Provided
Publications * Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.

*   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 February 2011
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon or rectum

    • Metastatic or recurrent disease not amenable to potentially curative treatment
  • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

    • Histological or cytological confirmation is required for a solitary target lesion
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

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 2 times upper limit of normal (ULN)
  • SGPT and SGOT no greater than 3 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 30 mL/min

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No clinical evidence of congestive heart failure
  • No unstable coronary artery disease

Pulmonary

  • No interstitial pneumonia
  • No extensive symptomatic fibrosis of the lungs

Gastrointestinal

  • Able to tolerate oral medication
  • No lack of physical integrity of the upper gastrointestinal tract
  • No malabsorption syndrome
  • No swallowing difficulties

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • No other concurrent serious illness
  • No uncontrolled infection
  • No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix or any other cancer for which the patient has been off all therapy and in remission for at least 5 years
  • No peripheral neuropathy
  • No hypersensitivity to any of the study drugs or their ingredients
  • No known dihydropyrimidine dehydrogenase deficiency
  • No other medical or psychiatric disorder that would preclude giving informed consent or complying with study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic hematopoietic growth factor therapy
  • No prior bevacizumab (Avastin™)

Chemotherapy

  • At least 6 months since prior adjuvant fluorouracil, leucovorin calcium, and irinotecan
  • No prior oxaliplatin
  • No prior chemotherapy for metastatic or recurrent disease
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy unless for the control of bone pain

Surgery

  • Recovered from prior surgery
  • No prior organ allografts

Other

  • More than 4 weeks since prior investigational drugs
  • No concurrent iced mouth rinses for the prevention of stomatitis
  • No concurrent cold cap alopecia prevention
  • No concurrent pyridoxine
  • No concurrent sorivudine or chemically-related analogues (e.g., brivudine)
  • No concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, or warfarin
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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00062426
Other Study ID Numbers  ICMJE CDR0000304771
PROLOGUE-SANOFI-ARD5099
SANOFI-ARD5099
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 Prologue Research International
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Richard A. Gams, MD Prologue Research International
Investigator: Lauri Welles, MD Sanofi-Synthelabo
PRS Account National Cancer Institute (NCI)
Verification Date April 2004

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