A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:June 30, 2014
End Date:February 1, 2017

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A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 (Vanucizumab) Plus FOLFOX Versus Bevacizumab Plus FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer

This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab
to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic
acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in
participants with previously untreated metastatic colorectal cancer (mCRC). The study
consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized,
parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants
will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm
the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will
be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 +
bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each
14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either
bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic
acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression,
unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.


Inclusion Criteria:

- Histologically or cytologically confirmed mCRC not amenable to potentially curative
resection with at least one measurable metastatic lesion, as defined by RECIST v1.1

- Eastern Cooperative Oncology Group (World Health Organization) performance status of 0
or 1

- Adequate hematologic, liver, coagulation, renal, and cardiovascular function

- Recovery from all reversible AEs of previous medical therapies to baseline or National
Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 1,
except for alopecia (any grade)

- Negative serum pregnancy test within 7 days prior to starting study treatment in
premenopausal women and women less than (< 2) years after the onset of menopause

Exclusion Criteria:

- Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase
inhibitors, immunotherapy, hormonal therapy) before Day 1 of Cycle 1 for treatment of
mCRC

- Malignancies other than CRC within 5 years prior to randomization, except for those
with a minimal risk of metastasis or death, such as adequately treated carcinoma in
situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer,
ductal carcinoma in situ treated surgically with curative intent

- Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to
Day 1 of Cycle 1, except palliative radiotherapy to bone lesions within 7 days prior
to Day 1 of Cycle 1

- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to Day 1 of Cycle

- Pregnant or lactating women

- Symptomatic central nervous system (CNS) metastases or carcinomatous meningitis.
Asymptomatic patients must be clinically stable with regard to their CNS/ meningeal
metastatic involvement, have completed previous therapy (including radiation and/ or
surgery) at least 4 weeks prior to study drug administration, are not receiving
steroid therapy or taper, and are not receiving anti-convulsive medication for any CNS
involvement

- Active infection requiring IV antibiotics

- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory
drugs (NSAIDs), inhaled corticosteroids, or the equivalent of less than or equal to
(
- Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2

- Significant cardiovascular or cerebrovascular disease within 6 months prior to Day 1
of Cycle 1

- Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation

- Current use of anticoagulants at therapeutic doses within 7 days prior to study drug
administration. Prophylactic use of unfractioned heparin or low molecular weight
heparin is permitted

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1 of Cycle 1 or abdominal surgery, abdominal interventions or significant
abdominal traumatic injury within 60 days prior to Day 1 of Cycle 1

- History of intra-abdominal inflammatory process within 6 months prior to Day 1 of
Cycle 1 including but not limited to peptic ulcer disease, diverticulitis, or colitis

- Colonic prosthesis (stent) implant in place

- History of abdominal or tracheo-oesophageal fistula or gastrointestinal (GI)
perforation or intra abdominal abscess within 6 months prior to Day 1 of Cycle 1

- History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction
including sub-occlusive disease related to the underlying disease or a requirement for
routine parenteral hydration, parenteral nutrition, or tube feeding within 6 months
prior to Day 1 of Cycle 1

- Chronic daily treatment with NSAID (occasional use for the symptomatic relief of
medical conditions, for example headache or fever is allowed)

- Chronic daily treatment with corticosteroids (dose > 10 mg/day methylprednisolone
equivalent) excluding inhaled steroids

- Evidence of abdominal free air not explained by paracentesis or recent surgical
procedure

- Metastatic disease that involve major airways or blood vessels, or centrally located
mediastinal tumor masses (< 30 millimeter from the carina) of large volume

- History of bronchopulmonary hemorrhage NCI CTCAE >/= Grade 2 within 2 months prior to
randomization

- Severe, nonhealing or open wound, active ulcer, or untreated bone fracture

- Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene
polymorphism predisposing the patient for 5-FU toxicity

- Any other condition, diseases, metabolic dysfunction, active or uncontrolled
infections/inflammation, physical examination finding, mental status or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates participation in the clinical study due to safety concerns, compliance
with clinical study procedures or that may affect the interpretation of the results
We found this trial at
18
sites
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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433 Southwest 10th Street
Ocala, Florida 34471
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Birmingham, Alabama 35223
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Chattanooga, Tennessee 37404
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Encinitas, CA
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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1791 East Fir Avenue
Fresno, California 93720
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La Jolla, CA
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10833 Le Conte Avenue
Los Angeles, California 90095
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Nashville, Tennessee 37203
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Ogden, Utah 84403
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San Antonio, Texas 78229
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Sepulveda, California 91343
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Tucson, Arizona 85712
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Waratah, New South Wales 2298
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