A Study to Evaluate Avastin in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

NCT00109226 | Completed Phase 2

• 1 other identifier: AVF2192g
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Colorectal Cancer

Keywords

Metastatic Colorectal Cancer; Cancer

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (3)

• 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

• 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

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2005
• First Posted: April 26, 2005
• Study Start: August 1, 2000
• Study Completion: September 1, 2003
• Last Updated: April 8, 2014

Record last verified: 2014-04