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Advanced Colorectal CancerPhase 2NCT00386828

Chemoradiation for Locally Advanced and Low Rectal Cancers: Avastin-Capecitabine-Oxaliplatin-Radiation REctal Cancer Trial

A Phase 2 study testing Bevacizumab: in people with Advanced Colorectal Cancer, run by British Columbia Cancer Agency at 6 sites in Canada.

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 study will evaluate the effect of bevacizumab, capecitabine and oxaliplatin with radiation on rectal cancer. Researchers will also evaluate the tolerability (how it makes the patient feel) and safety of this combination by watching for harmful side-effects.It is hoped that by adding bevacizumab to the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
Bevacizumab:
How many people
43 participants
Where
6 sitesCanada
Study dates
Oct 2006to May 2009
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

  • Histologically confirmed adenocarcinoma of the rectum, defined as either:
  • Mid- or upper rectal tumours (>= 6 - 15 cm): T3 or T4 adenocarcinoma that is fixed or partially fixed or tethered and is potentially resectable; or Low rectal tumours (<6cm): T3 or T4 adenocarcinoma: or Node positive rectal tumours (<= 15cm): T1-4N2 or T1-4N+ where pelvic nodes approach or invade the mesorectum.
  • M0/X or M1 is permitted as long as definitive resection of the primary tumour is planned and, in the opinion of the investigator, it is safe to delay full dose of systemic chemotherapy
  • Appropriate staging investigations of the primary tumour, either endorectal ultrasound or pelvic MRI.
  • Male or female aged 18 or older.
  • Have a performance status ECOG of 0 or 1.
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  • Have a life expectancy greater than 6 months.
  • Adequate organ function and coagulation parameters as measured by:
  • ANC >=1.5 platelets >=100 Serum creatinine <= 1.5X ULN AST, ALT <= 2.5X ULN Bilirubin <= 1.5 ULN PTT and INR within normal limits Albumin >= than 30
  • Patient consent
  • No neurological diseases that can increase the neurotoxicity of oxaliplatin
  • Be willing and able to comply with the protocol for the duration of the study.

Who cannot join

  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day -14, (i.e. patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during or within 7 weeks after chemo-radiotherapy.
  • Known to have clinical or radiological evidence of CNS metastases.
  • Patients with a past or current history (within last 2 years) of other malignancies, except for the indication under this study and curatively treated basal and squamous skin cancer or in-situ cancer of the cervix.
  • Women of childbearing potential with either a positive or no pregnancy test at baseline or lactating. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. Patients of childbearing potential must be willing to use a reliable method of birth control. i.e.: doublebarrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation during the study
  • Evidence of bleeding diathesis or coagulopathy.
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  • Uncontrolled hypertension, defined as SBP > 150/100 on more than one occasion that does not respond to therapy with antihypertensive agents
  • Clinically significant (i.e. active) cardiovascular disease for example:
  • cerebrovascular accidents (<=6 months), myocardial infarction (<= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
  • Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes i.e. except for anticoagulation for maintenance of patency of permanent indwelling IV catheters.
  • Evidence 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 puts the patient at high risk from treatment complications.
  • Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
  • Any other serious or uncontrolled illnesses.
  • Current or recent serious polyneuropathy.
  • Known hypersensitivity against bevacizumab.
  • Known peripheral neuropathy >= NCI CTCAE grade 1. Absence of deep tendon reflexes (DTRs) as the sole neurologic abnormality does not render the patient ineligible.
  • Organ allografts requiring immunosuppressive therapy.
  • Serious, non-healing wound, ulcer, or bone fracture.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • BCCA - Centre for Southern Interior

    Kelowna, British Columbia

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario

  • BC Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: Phase II Study of Chemoradiation for Locally Advanced and Low Rectal Cancers: Avastin-Capecitabine-Oxaliplatin-Radiation REctal Cancer Trial

This phase II study will evaluate the effect of bevacizumab, capecitabine and oxaliplatin with radiation on rectal cancer. Researchers will also evaluate the tolerability (how it makes the patient feel) and safety of this combination by watching for harmful side-effects.It is hoped that by adding bevacizumab to the capecitabine/oxaliplatin treatment in combination with radiation before surgery will improve response rate.

Read the detailed description

Improved pre-operative therapy is required in the management of high risk rectal cancer in order to decrease local recurrence and increase the rate of sphincter sparing surgery. Capecitabine, oxaliplatin and bevacizumab represent new systemic agents and have been given safely in phase I and II trials concurrently with radiation with promising improvements in pCR rates of 15 -24% compared to historic rates of 8-14% achieved with 5-FU alone. Improvements in pCR rates have not been associated with an increase in post-operative complication rates. A trial of all three of these agents is justified due to their enhanced efficacy when given in combination as well as their non-overlapping treatment toxicity profile.

This is a one-armed, multi-centred, Phase II study in patients with T3/4 locally advanced and T3/4 low lying rectal cancer, to study the efficacy and safety of the addition of bevacizumab to a regimen of capecitabine and oxaliplatin in combination with pre-operative radiation.

Being tested
Bevacizumab:
Keywords
colorectal cancer, advanced colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is pathologic complete response (pCR) rate

Secondary outcomes (3)

  1. Rate of Sphincter Sparing Surgery:

  2. Complete Resection Rate

  3. Post-Surgical Complication Rates:

Timeline

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

  1. First posted12 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionMay 2009
  4. Study completionMay 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00386828
Sponsor's protocol ID
PROTOCOL NUMBER: OZM-004
Other IDs
A-CORRECT Study
Status last verified
Nov 2010
First submitted
11 Oct 2006
Last updated
25 Nov 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab: in people with Advanced Colorectal Cancer, run by British Columbia Cancer Agency at 6 sites in Canada.

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 12 inclusion and 18 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 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does the primary outcome measure?

The primary endpoint is pathologic complete response (pCR) rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00386828.

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 25 Nov 2010.

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