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A Study to Evaluate Avastin in Combination With Chemotherapy in 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: NCT00109226
Recruitment Status : Completed
First Posted : April 26, 2005
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE April 26, 2005
First Posted Date  ICMJE April 26, 2005
Last Update Posted Date April 8, 2014
Study Start Date  ICMJE August 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 A Study to Evaluate Avastin in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE A Phase II, Multicenter, Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of rhuMAb VEGF (Bevacizumab), a Recombinant Humanized Monoclonal Antibody to Vascular Endothelial Growth Factor, in Combination With 5-Fluorouracil and Leucovorin Chemotherapy in Subjects With Metastatic Colorectal Cancer Who Are Not Optimal Candidates for First Line CPT-11
Brief Summary This Phase II, multicenter, double-blind, randomized, active-controlled trial is designed to evaluate the efficacy and safety of rhuMAb VEGF (Avastin) when administered at a dose of 5 mg/kg every 2 weeks in combination with 5 FU (fluorouracil)/leucovorin versus 5 FU/leucovorin alone in subjects with previously untreated metastatic colorectal cancer who are not optimal candidates to receive first-line CPT-11 (irinotecan). A total of 48 doses of rhuMAb VEGF may be administered during this study (maximum of 96 weeks of therapy).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: Avastin (Bevacizumab)
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent
  • Age >=18 years
  • Use of an effective means of contraception in women of childbearing potential
  • Histologically confirmed (resected or biopsied primary tumor) colorectal carcinoma with evidence of metastases (i.e., by radiographic imaging or biopsy)
  • Ability to tolerate CT contrast dye.
  • Bi-dimensionally measurable disease (minimum of two lesions)
  • Life expectancy of >3 months
  • Willingness and capability to be accessible for follow-up until death
  • In addition, subjects must meet at least one of the following criteria to be eligible for study entry: *Age >=65 years; *ECOG performance status of 1 or 2; *Albumin <=3.5 g/dL; *Prior radiotherapy to the abdomen or pelvis; and, *in the opinion of the treating physician, not be an optimal candidate for first-line CPT-11

Exclusion Criteria:

  • Prior administration of chemotherapy other than adjuvant fluoropyrimidines in combination with leucovorin and/or levamisole
  • Administration of adjuvant fluoropyrimidines in combination with leucovorin and/or levamisole completed <=12 months prior to Day 0
  • Administration of fluoropyrimidines as a radiosensitizer during pelvic radiotherapy for rectal cancer completed <=12 months prior to Day 0
  • Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response
  • Radiotherapy within 14 days prior to Day 0
  • Prior administration of biotherapy for colorectal cancer
  • Evidence of clinically detectable ascites prior to Day 0
  • Other invasive malignancies within 5 years of Day 0 (other than basal cell carcinoma of the skin)
  • History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases)
  • Serious, nonhealing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedure within 28 days prior to Day 0, or open biopsy, significant traumatic injury, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations within 7 days prior to Day 0
  • Current or recent (within the 10 days prior to Day 0) use of oral or parenteral anticoagulants (except as required to maintain patency of preexisting, permanent indwelling IV catheters) or thrombolytic agent
  • Chronic, daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory medications (of the kind known to inhibit platelet function)
  • Pregnancy (positive pregnancy test) or lactation
  • Proteinuria at baseline or clinically significant impairment of renal function
  • Current or recent (within 28 days prior to Day 0) participation in another experimental drug study
  • Active infection requiring parenteral antibiotics on Day 0
  • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix H), serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year prior to Day 0
  • ECOG performance status of >2
  • Screening clinical laboratory values: *ANC of <=1500/uL; *Platelet count of <=75,000/uL; *International normalized ratio (INR) of >=1.5; *Total bilirubin of >2.0 mg/dL; *AST or ALT of >=5 times the upper limit of normal for subjects with documented liver metastases; >2.5 times the upper limit of normal for subjects without evidence of liver metastases; *Serum creatinine of >2.0 mg/dL; *Hemoglobin of <9 gm/dL (may be transfused to maintain or exceed this level); *Proteinuria (24-hour urine collection demonstrated >=500 mg of protein/24 hr)
  • 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 interpretation of the results of the study or render the subject at high risk from treatment complications
  • Inability to comply with the study visit and follow-up schedule or procedures
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 NCT00109226
Other Study ID Numbers  ICMJE AVF2192g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Genentech, Inc.
Verification Date April 2014

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