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Colorectal CancerPhase 2NCT01490866

A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

A Phase 2 study testing Axitinib, Bevacizumab and 5-Fluorouracil in people with Colorectal Cancer, run by SCRI Development Innovations, LLC at 12 sites in United States.

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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Axitinib, Bevacizumab and 5-Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
12 sitesUnited States
Study dates
Jan 2012to Jul 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 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
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Texas Health Physician Group

    Dallas, Texas, 75243

  • Florida Cancer Specialists-South

    Fort Myers, Florida, 33916

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Grand Rapids Oncology Program

    Grand Rapids, Michigan, 49503

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Oncology Hematology of SW Indiana

    Newburgh, Indiana, 47630

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Woodlands Medical Specialists

    Pensacola, Florida, 32503

  • Florida Cancer Specialists-North

    St. Petersburg, Florida, 33705

  • Atlantic Health System

    Summit, New Jersey, 07901

  • Hope Cancer Center

    Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: A Phase II Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

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.

Read the 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 having significant benefit from FOLFOX/bevacizumab may continue chemotherapy to a maximum of six 28-day cycles. During trial treatment, all patients will be assessed for response every 8 weeks (2 cycles).

Keywords
Colorectal Cancer, Axitinib, FOLFOX/Bevacizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • AxitinibDrug

    Also called AG-013736

    5-mg tablets PO BID

  • BevacizumabDrug

    Also called Avastin

    5 mg/kg Days 1 and 15; IV

  • 5-FluorouracilDrug

    Also called 5-FU

    400 mg/m2 Days 1 and 15; IV

  • 5-FluorouracilDrug

    Also called 5-FU

    2400 mg/m2 over 46-48 hours Days 1 and 15; Continuous Intravenous

  • LeucovorinDrug

    Also called folinic acid

    400 mg/m2 Days 1 and 15; IV

  • OxaliplatinDrug

    Also called Eloxatin

    85 mg/m2 Days 1 and 15; IV

Study groups in NCT01490866
Study groupRoleWhat they receive
FOLFOX/bevacizumab and AxitinibExperimentalPhase 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.
Receives: Drug: Axitinib; Drug: Bevacizumab; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

What is being measured

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

  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.

    Measured: 24 months

Secondary outcomes (4)

  1. Objective Response Rate

    Defined as the percentage of evaluable patients showing a complete or partial response (CR or PR) per RECIST v1.1 criteria. CR = disappearance of all lesions. PR = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since start of treatment.

    Measured: every 8 weeks, assessed up to approximately 24 months

  2. Time To Progression (TTP)

    Defined as the time after a disease is diagnosed (or treated) until worsening of the disease.

    Measured: every 8 weeks, assessed approximately up to 24 months

  3. Overall Survival (OS)

    Defined as the time from first treatment until death from any cause.

    Measured: every 8 weeks until progression then every 3 months for up to 5 years.

  4. Frequency of Adverse Events as a Measure of Safety

    The frequency of adverse events (AEs) was analyzed in 2 groups of patients, those receiving FOLFOX/bevacizumab (N=70), and patients who received axitinib maintenance (N = 48). AEs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.

    Measured: Every 4 weeks plus 30 days during treatment and up to 5 years thereafter.

Timeline

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

  1. First posted13 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2015
  4. Study completionJul 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01490866
Sponsor's protocol ID
SCRI GI 154
Status last verified
Sep 2019
First submitted
7 Nov 2011
Last updated
24 Sep 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Axitinib, Bevacizumab and 5-Fluorouracil in people with Colorectal Cancer, run by SCRI Development Innovations, LLC at 12 sites in United States.

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 10 inclusion and 27 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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?

Yes. Results are posted in the registry (first posted 12 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (time frame: 24 months). 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 NCT01490866.

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 24 Sep 2019.

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