A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)
A Phase II Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)
1 other identifier
interventional
70
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 colorectal-cancer
Started Jan 2012
Typical duration for phase_2 colorectal-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
December 13, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
January 12, 2017
CompletedSeptember 24, 2019
September 1, 2019
3.5 years
November 7, 2011
September 21, 2016
September 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Defined as the time from first treatment until objective tumor progression or death from any cause, assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
24 months
Secondary Outcomes (4)
Objective Response Rate
every 8 weeks, assessed up to approximately 24 months
Time To Progression (TTP)
every 8 weeks, assessed approximately up to 24 months
Overall Survival (OS)
every 8 weeks until progression then every 3 months for up to 5 years.
Frequency of Adverse Events as a Measure of Safety
Every 4 weeks plus 30 days during treatment and up to 5 years thereafter.
Study Arms (1)
FOLFOX/bevacizumab and Axitinib
EXPERIMENTALPhase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC. (FOLFOX is a combination of 5-Fluorouracil, Leucovorin and Oxaliplatin.) All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Pfizercollaborator
Study Sites (12)
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Florida Cancer Specialists-South
Fort Myers, Florida, 33916, United States
Woodlands Medical Specialists
Pensacola, Florida, 32503, United States
Florida Cancer Specialists-North
St. Petersburg, Florida, 33705, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Oncology Hematology of SW Indiana
Newburgh, Indiana, 47630, United States
Hope Cancer Center
Terre Haute, Indiana, 47802, United States
Grand Rapids Oncology Program
Grand Rapids, Michigan, 49503, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Atlantic Health System
Summit, New Jersey, 07901, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Texas Health Physician Group
Dallas, Texas, 75243, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles H. Davis, RAC
- Organization
- SCRI Development Innovations
Study Officials
- STUDY CHAIR
Johanna Bendell, M.D.
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
December 13, 2011
Study Start
January 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
September 24, 2019
Results First Posted
January 12, 2017
Record last verified: 2019-09