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

NCT01490866

Last updated date
Study Location
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)
Official Title  ICMJE A Phase II Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)
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 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Axitinib
    5-mg tablets PO BID
    Other Name: AG-013736
  • Drug: Bevacizumab
    5 mg/kg Days 1 and 15; IV
    Other Name: Avastin
  • Drug: 5-Fluorouracil
    400 mg/m2 Days 1 and 15; IV
    Other Name: 5-FU
  • Drug: 5-Fluorouracil
    2400 mg/m2 over 46-48 hours Days 1 and 15; Continuous Intravenous
    Other Name: 5-FU
  • Drug: Leucovorin
    400 mg/m2 Days 1 and 15; IV
    Other Name: folinic acid
  • Drug: Oxaliplatin
    85 mg/m2 Days 1 and 15; IV
    Other Name: Eloxatin
Study Arms  ICMJE Experimental: FOLFOX/bevacizumab and Axitinib

Phase 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:
  • Drug: Axitinib
  • Drug: Bevacizumab
  • Drug: 5-Fluorouracil
  • Drug: 5-Fluorouracil
  • Drug: Leucovorin
  • Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2015)
70
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2011)
69
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01490866
Other Study ID Numbers  ICMJE SCRI GI 154
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SCRI Development Innovations, LLC
Study Sponsor  ICMJE SCRI Development Innovations, LLC
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Johanna Bendell, M.D.SCRI Development Innovations, LLC
PRS Account SCRI Development Innovations, LLC
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP