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

NCT00109070 | Completed Phase 3

• 1 other identifier: AVF2107g
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Metastatic

Interventions

Avastin (bevacizumab) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (6)

• 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. doi: 10.1093/jnci/djm086. Epub 2007 Aug 8.

  PMID: 17686822 RESULT

• 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. doi: 10.1634/theoncologist.2008-0003. Epub 2008 Sep 5.

  PMID: 18776057 RESULT

• 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. doi: 10.1200/JCO.2007.13.8099.

  PMID: 18182660 RESULT

• 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. doi: 10.1200/JCO.2008.17.7931. Epub 2008 Dec 8.

  PMID: 19064978 RESULT

• 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. doi: 10.1007/s00280-007-0664-8. Epub 2008 Jan 19.

  PMID: 18205003 RESULT

• 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. doi: 10.1634/theoncologist.2008-0213. Epub 2009 Jan 14.

  PMID: 19144677 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2005
• First Posted: April 25, 2005
• Study Start: September 1, 2000
• Study Completion: April 1, 2003
• Last Updated: June 21, 2013

Record last verified: 2013-06