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Trial record 71 of 436 for:    colon cancer AND Capecitabine

Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00416494
Recruitment Status : Completed
First Posted : December 28, 2006
Results First Posted : March 14, 2013
Last Update Posted : September 3, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Herbert Hurwitz, MD, Duke University

Tracking Information
First Submitted Date  ICMJE December 27, 2006
First Posted Date  ICMJE December 28, 2006
Results First Submitted Date  ICMJE February 12, 2013
Results First Posted Date  ICMJE March 14, 2013
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE September 2003
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
Response Rate (Percentage of Participants With Partial or Complete Response) [ Time Frame: After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months. ]
Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression. Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. The definitions were: Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00416494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
  • Time to Progression [ Time Frame: From time of treatment until documented progression, assesed up to 60 months. ]
    Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
  • Disease Free Survival [ Time Frame: From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months. ]
    Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
  • Overall Survival [ Time Frame: From time of treatment until death from any cause, assesed up to 60 months. ]
    Average months of survival of participants after receiving study drug.
  • Safety and Tolerability [ Time Frame: After all participants went off study drug regimine. ]
    Number of participants with adverse events
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 12, 2013)
  • Effect on Angiogenesis Biomarkers [ Time Frame: After study completion ]
  • Effect on Wound Angiogenesis [ Time Frame: After study completion ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Official Title  ICMJE Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the response rate in patients with previously untreated metastatic colorectal cancer treated with capecitabine, oxaliplatin, and bevacizumab.

Secondary

  • Assess time to progression (TTP), disease-free survival (DFS), and overall survival (OS) in patients treated with this regimen.
  • Assess the safety and tolerability of bevacizumab, oxaliplatin, and capecitabine in patients with previously untreated metastatic colorectal cancer.

Exploratory

  • Evaluate the effect of this regimen on the biomarkers of angiogenesis.
  • Assess the effect of this regimen on wound angiogenesis.

OUTLINE: Patients receive oral capecitabine twice daily on days 1-5 and 8-12, oxaliplatin IV over 2 hours on day 1, and bevacizumab IV over 1-1½ hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Biological: bevacizumab
    10 mg/kg intravenously over 30-90 minutes on day 1
  • Drug: oxaliplatin
    85 mg/m2 intravenously over 2 hours on day 1.
  • Drug: Capecitabine
    Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
  • Drug: Capecitabine
    Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
Study Arms  ICMJE
  • Experimental: Initial Cohort
    Interventions:
    • Biological: bevacizumab
    • Drug: oxaliplatin
    • Drug: Capecitabine
  • Experimental: Second cohort
    Interventions:
    • Biological: bevacizumab
    • Drug: oxaliplatin
    • Drug: Capecitabine
Publications *

*   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: February 12, 2013)
50
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically documented adenocarcinoma of the colon or rectum

    • Metastatic or recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease)
  • No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • AST/ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if known liver metastases)
  • Bilirubin < 1.5 times ULN
  • Creatinine clearance > 50 mL/min
  • No unstable or poorly controlled hypertension (> 150/100 mm Hg)

    • Patients who have recently started or adjusted antihypertensive medications are eligible provided blood pressure is < 140/90 mm Hg on any new regimen for at least 3 different observations over 14 days
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study and for at least 3-4 months after study completion
  • No arterial or venous thrombosis (including cerebrovascular accident) within the last 3 months
  • No known, existing, uncontrolled coagulopathy
  • No clinically significant cardiac disease
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No cardiac arrhythmias not well controlled with medication
  • No myocardial infarction within the last 12 months
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or bevacizumab
  • No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior sorivudine or brivudine
  • At least 6 months since prior adjuvant treatment with fluorouracil and leucovorin calcium or a fluorouracil and leucovorin calcium-based regimen
  • No major surgery within 4 weeks without complete recovery
  • No prior chemotherapy for metastatic/recurrent disease
  • No cancer immunotherapy or other biologic therapy while on therapy
  • No radiotherapy while on study
  • No hormonal therapy for cancer while on study
  • No full-dose warfarin (INR of > 1.5), heparin (> 10,000 units/day), or thrombolytic agents
  • Allopurinol and cimetidine should be discontinued prior to starting on this regimen
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00416494
Other Study ID Numbers  ICMJE Pro00008646
DUMC-4951-05-7R2
GENENTECH-DUMC-4951-05-7R2
SANOFI-DUMC-4951-05-7R2
ROCHE-DUMC-4951-05-7R2
CDR0000449971 ( Other Identifier: NCI )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Herbert Hurwitz, MD, Duke University
Study Sponsor  ICMJE Herbert Hurwitz, MD
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Herbert I. Hurwitz, MD Duke Cancer Institute
PRS Account Duke University
Verification Date August 2014

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