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

Phase 2
18 Years
Not Enrolling
Advanced Colorectal Cancer

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Trial Information

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

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

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

Inclusion Criteria:

- 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

- 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.

- 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.

Exclusion Criteria:

- 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

- 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.

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is pathologic complete response (pCR) rate

Principal Investigator

Hagen Kennecke, MD

Investigator Role:

Study Chair

Investigator Affiliation:

BC Cancer Agency -Vancouver Centre


Canada: Health Canada

Study ID:




Start Date:

October 2006

Completion Date:

May 2009

Related Keywords:

  • Advanced Colorectal Cancer
  • colorectal cancer
  • advanced colorectal cancer
  • Rectal Neoplasms
  • Colorectal Neoplasms