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Trial record 30 of 579 for:    colon cancer | ( Map: California, United States )

Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00159432
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : January 15, 2014
Last Update Posted : July 29, 2014
Sponsor:
Collaborators:
Hoffmann-La Roche
Genentech, Inc.
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE November 27, 2013
Results First Posted Date  ICMJE January 15, 2014
Last Update Posted Date July 29, 2014
Study Start Date  ICMJE February 2005
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
Median Time for Progression Free Survival [ Time Frame: Up to 6 years ]
Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
To determine the median time for progression free survival in patients with advanced colorectal cancer treated with a combination of capecitabine, oxaliplatin and bevacizumab.
Change History Complete list of historical versions of study NCT00159432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2014)
Number of Participants With Grade 3 or Higher Toxicity [ Time Frame: Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months. ]
Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • To determine the time to progression, overall response rate and overall survival in patients with advanced colorectal cancer treated with a combination of capecitabine, oxaliplatin and bevacizumab.
  • To assess the toxicity of this regimen.
  • To confirm the association of TS, TP, DPD, and ERCC1 expression levels in tumor tissue with clinical outcome.
  • To identify other molecular predictors of response, survival, and toxicity to this combination of chemotherapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer
Official Title  ICMJE Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer
Brief Summary This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. This study is being done to find out how long it takes tumors to grow after patients receive the drugs capecitabine, oxaliplatin and bevacizumab. Capecitabine (also called Xeloda) is a drug that has been approved by the FDA for treatment of advanced colorectal cancer. Capecitabine prevents some colorectal cancer cancer cells from reproducing, and causes some of them to die. Oxaliplatin (also called Eloxatin) has also been approved by the FDA for treatment of advanced colorectal cancer. Oxaliplatin prevents some colorectal cancer cells from reproducing. Bevacizumab is an investigational drug. Bevacizumab is an antibody (a protein that acts against a specific substance) directed against vascular endothelial growth factor (VEGF). VEGF promotes the growth of blood vessels that bring nutrients to cells. Bevacizumab inhibits the growth of colon cancer cells, by blocking the effects of VEGF. The combination of the drugs used in this study is experimental. The purpose of this study is to see how long it takes patients' tumors to grow when they are taking this combination of drugs.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Oxaliplatin
    Other Name: Eloxatin
  • Drug: Bevacizumab
    Other Name: Avastin
  • Drug: Capecitabine
    Other Name: Xeloda
Study Arms  ICMJE Experimental: Oxaliplatin, followed by Bevacizumab with Capecitabine
oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Interventions:
  • Drug: Oxaliplatin
  • Drug: Bevacizumab
  • Drug: Capecitabine
Publications * Hurwitz H, Mitchell EP, Cartwright T, Kwok A, Hu S, McKenna E, Patt YZ. A randomized, phase II trial of standard triweekly compared with dose-dense biweekly capecitabine plus oxaliplatin plus bevacizumab as first-line treatment for metastatic colorectal cancer: XELOX-A-DVS (dense versus standard). Oncologist. 2012;17(7):937-46. doi: 10.1634/theoncologist.2012-0071. Epub 2012 May 23.

*   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: November 6, 2013)
63
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
53
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
  • Age greater than or equal to 18 years
  • SWOG performance status 0-1.
  • At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.
  • Have a negative serum pregnancy test within 7 days prior to initiation of chemotherapy (female patients of childbearing potential).
  • Availability of tumor biopsy (paraffin embedded or fresh frozen) at the time of diagnosis and/or prior to study entry is required.
  • Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.

Exclusion Criteria:

  • Pregnant or lactating woman.
  • Life expectancy < 3 months.
  • Serious, uncontrolled, concurrent infection(s) or illness(es)
  • Any prior oxaliplatin treatment, with the exception of adjuvant therapy given > 12 months prior to the beginning of study therapy
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-fluorouracil, or known DPD deficiency
  • Prior unanticipated severe reaction or hypersensitivity to platinum based compounds.
  • Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
  • Current, recent (within 4 weeks of first infusion on this study) or planned participation in an investigational drug study.
  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months.
  • History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
  • History of persistent neurosensory disorder including but not limited to peripheral neuropathy.
  • Presence of central nervous system or brain mets.
  • Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
  • Any of the following laboratory values:

    • Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x 109/L)
    • Urine protein: creatinine ratio >/= 1.0 Impaired renal function with estimated creatinine clearance < 30 ml/min as calculated with Cockroft et Gault equation:
    • Serum bilirubin > 1.5 x upper normal limit. ALT, AST > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases)
    • Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases or > 10 x upper normal limit in the case of bone disease)
  • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
  • Blood pressure > 150/100 mmHg
  • Unstable angina
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0.
  • Serious, non-healing wound, ulcer or bone fracture
  • Carcinoma of any histology in close proximity to a major vessel, cavitation or history of hemoptysis.
  • Completion of previous adjuvant chemotherapy regimen < four weeks prior to the start of study treatment (within six weeks of study treatment for mitomycin C and nitroureas), or with related toxicities unresolved prior to the start of study treatment.
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 NCT00159432
Other Study ID Numbers  ICMJE 3C-04-10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE
  • Hoffmann-La Roche
  • Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Syma Iqbal, M.D. U.S.C. Norris Comprehensive Cancer Center
PRS Account University of Southern California
Verification Date July 2014

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