Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study to Evaluate Avastin in Combination With Standard Chemotherapy to Treat Colorectal Cancer
This study has been completed.
First Received: April 22, 2005   Last Updated: September 1, 2009   History of Changes
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00109070
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control, Safety/Efficacy Study
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:

  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
No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
Scappaticci FA, Skillings JR, Holden SN, Gerber HP, Miller K, Kabbinavar F, Bergsland E, Ngai J, Holmgren E, Wang J, Hurwitz H. Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst. 2007 Aug 15;99(16):1232-9. Epub 2007 Aug 8.
Kabbinavar FF, Wallace JF, Holmgren E, Yi J, Cella D, Yost KJ, Hurwitz HI. Health-related quality of life impact of bevacizumab when combined with irinotecan, 5-fluorouracil, and leucovorin or 5-fluorouracil and leucovorin for metastatic colorectal cancer. Oncologist. 2008 Sep;13(9):1021-9. Epub 2008 Sep 5.
Grothey A, Hedrick EE, Mass RD, Sarkar S, Suzuki S, Ramanathan RK, Hurwitz HI, Goldberg RM, Sargent DJ. Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. J Clin Oncol. 2008 Jan 10;26(2):183-9.
Kabbinavar FF, Hurwitz HI, Yi J, Sarkar S, Rosen O. Addition of bevacizumab to fluorouracil-based first-line treatment of metastatic colorectal cancer: pooled analysis of cohorts of older patients from two randomized clinical trials. J Clin Oncol. 2009 Jan 10;27(2):199-205. Epub 2008 Dec 8.
Lu JF, Bruno R, Eppler S, Novotny W, Lum B, Gaudreault J. Clinical pharmacokinetics of bevacizumab in patients with solid tumors. Cancer Chemother Pharmacol. 2008 Oct;62(5):779-86. Epub 2008 Jan 19.
Hurwitz HI, Yi J, Ince W, Novotny WF, Rosen O. The clinical benefit of bevacizumab in metastatic colorectal cancer is independent of K-ras mutation status: analysis of a phase III study of bevacizumab with chemotherapy in previously untreated metastatic colorectal cancer. Oncologist. 2009 Jan;14(1):22-8. Epub 2009 Jan 14.

Study ID Numbers: AVF2107g
Study First Received: April 22, 2005
Last Updated: September 1, 2009
ClinicalTrials.gov Identifier: NCT00109070     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Metastatic

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Bevacizumab
Intestinal Diseases
Angiogenesis Inhibitors
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on September 03, 2009