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Colorectal CancerPhase 2NCT00109226

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

A Phase 2 study testing Avastin (Bevacizumab) in people with Colorectal Cancer, run by Genentech, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Avastin (Bevacizumab)
How many people
Not given
Where
No sites listed yet
Study dates
Aug 2000to Sep 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

About this study

Official title: 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

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).

Being tested
Avastin (Bevacizumab)
Keywords
Metastatic Colorectal Cancer, Cancer
Medical subject headings
Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avastin (Bevacizumab)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2005 (estimated)
  2. Study startAug 2000
  3. Study completionSep 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00109226
Sponsor's protocol ID
AVF2192g
Status last verified
Apr 2014
First submitted
26 Apr 2005
Last updated
8 Apr 2014
Results posted
No

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

    PubMed 17686822

  • 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.

    PubMed 18776057

  • 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.

    PubMed 19064978

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avastin (Bevacizumab) in people with Colorectal Cancer, run by Genentech, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00109226, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.

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