Status:
COMPLETED
A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Pfizer
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC.
Detailed Description
All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started. With approval of the Medical Monitor,patients who are h...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- Patients must have measurable disease per RECIST Version 1.1.
- No previous systemic therapy for metastatic colorectal cancer. Previous radiosensitizing chemotherapy is allowed, if completed at least 4 weeks prior to Cycle 1 Day 1 of study treatment, and previous neoadjuvant and/or adjuvant chemotherapy is allowed, if completed at least 6 months prior to diagnosis of metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
- Life expectancy \>=12 weeks.
- Adequate hematologic, renal and hepatic function
- Patients who are on coumadin should have an INR value within the therapeutic range (i.e., 2 to 3 x ULN). Patients who are on stable, chronic doses of coumadin are eligible.
- Male patients willing to use adequate contraceptive measures. Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test performed within 72 hours prior to start of treatment.
- Willingness and ability to comply with the trial and follow-up procedures.
- Ability to understand the investigative nature of this trial and give written informed consent.
Exclusion
- History or known presence of central nervous system (CNS) metastases.
- Patients who have had a major surgical procedure (not including mediastinoscopy), or significant traumatic injury \<=4 weeks prior to beginning treatment.
- Women who are pregnant or lactating. All females of child-bearing potential must have negative serum or urine pregnancy tests within 72 hours prior to study treatment (see Appendix D)
- History of hypersensitivity to active or inactive excipients of any component of treatment (5 fluorouracil, bevacizumab, oxaliplatin, or axitinib), or known dipyrimidine dehydrogenase deficiency.
- Patients with proteinuria at screening as demonstrated by:
- Urine dipstick for proteinuria \>=2+ (patients discovered to have \>=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection, and must demonstrate \<=1 g of protein/24 hours to be eligible)
- Patients with a serious non healing wound, active ulcer, or untreated bone fracture.
- Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- Patients with history of hematemesis or hemoptysis (defined as having bright red blood of ½ teaspoon or more per episode) \<=1 month prior to study enrollment.
- Patients requiring concomitant treatment with potent CYP3A4 or CYP1A2 inducers and CYP3A4 inhibitors.
- History of myocardial infarction or unstable angina \<=6 months prior to beginning treatment.
- Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg while on antihypertensive medications). Initiation of antihypertensive agents is permitted provided adequate control is documented at least 1 week prior to Day 1 of study treatment.
- New York Heart Association Grade II or greater congestive heart failure.
- Serious cardiac arrhythmia requiring medication. Patients with chronic, rate-controlled atrial fibrillation are eligible.
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) \<=6 months prior to Day 1 of treatment.
- History of stroke or transient ischemic attack \<=6 months prior to beginning treatment.
- Any prior history of hypertensive crisis or hypertensive encephalopathy.
- History of abdominal fistula or gastrointestinal perforation \<=6 months prior to Day 1 of beginning treatment.
- Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any known positive test for human immunodeficiency virus, hepatitis C virus or acute or chronic hepatitis B infection.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- Use of any non-approved or investigational agent \<=28 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
- Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a disease free survival \>=5 years.
- Infection requiring IV antibiotics.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g. active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or significant small bowel resection).
- Inability to swallow whole tablets.
- Patients with \> Grade 2 peripheral neuropathy.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01490866
Start Date
January 1 2012
End Date
July 1 2015
Last Update
September 24 2019
Active Locations (12)
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1
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
2
Florida Cancer Specialists-South
Fort Myers, Florida, United States, 33916
3
Woodlands Medical Specialists
Pensacola, Florida, United States, 32503
4
Florida Cancer Specialists-North
St. Petersburg, Florida, United States, 33705