A Study to Evaluate Avastin in Combination With Standard Chemotherapy to Treat Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00109070
First received: April 22, 2005
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

This is a multicenter, Phase III, randomized, active-controlled trial to evaluate the efficacy and safety of rhuMAb VEGF (Avastin) added to the standard first-line chemotherapy used to treat metastatic colorectal cancer. This trial will enroll approximately 900 subjects with histologically confirmed, previously untreated, bi-dimensionally measurable metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: Avastin (bevacizumab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of rhuMAb VEGF (Bevacizumab) in Combination With Standard Chemotherapy in Subjects With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Study Start Date: September 2000
Study Completion Date: April 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Age >=18 years
  • Histologically confirmed 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)
  • ECOG performance status of 0 or 1
  • Use of an effective means of contraception in women of childbearing potential
  • Life expectancy of >3 months
  • Willingness and capability to be accessible for follow-up until death or study termination by Genentech

Exclusion Criteria:

  • Prior 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
  • Radiation therapy within 14 days prior to Day 0
  • Prior biotherapy for colorectal cancer
  • Evidence of clinically detectable ascites on Day 0
  • Other invasive malignancies within 5 years prior to 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, any brain metastases, or history of stroke)
  • Active infection requiring parenteral antibiotics on Day 0
  • Major surgical procedure, 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; fine needle aspirations within 7 days prior to Day 0
  • Current or recent (within the 10 days prior to Day 0) use of full-dose oral or parenteral anticoagulants (except as required to maintain patency of preexisting, permanent indwelling IV catheters) or thrombolytic agent (for subjects receiving warfarin, international normalized ratio [INR] of <1.5; appropriate use of heparin should be discussed with the Medical Monitor)
  • Chronic, daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory medications (of the kind known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
  • Pregnancy (positive pregnancy test) or lactation
  • Proteinuria at baseline or clinically significant impairment of renal function
  • Serious, nonhealing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
  • Current or recent (within the 28 days prior to Day 0) participation in another experimental drug study
  • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year prior to Day 0
  • Screening clinical laboratory values: *ANC of <1500/uL; *Platelet count of <75,000/uL; *INR of >=1.5; *Total bilirubin of >1.6 mg/dL; *AST or ALT >=5 times 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)
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00109070     History of Changes
Obsolete Identifiers: NCT00012233
Other Study ID Numbers: AVF2107g
Study First Received: April 22, 2005
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Metastatic

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014