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

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

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

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).

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or

- Patients must have measurable disease per Response Evaluation Criteria in Solid
Tumors (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 liver function defined as:

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x the
institutional upper limit of normal (ULN) or ≤5.0 x the institutional ULN in
patients with liver metastases.

- Total bilirubin within normal limits (WNL) (or ≤1.5 x the institutional ULN in
patients with liver metastases; or total bilirubin ≤3.0 x ULN with direct
bilirubin within normal limits in patients with well documented Gilbert

- Adequate renal function defined as:

• Serum creatinine ≤1.5 mg/dL OR calculated 24-hour creatinine clearance ≥60 mL/min.

- 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

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.

- 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.

- Serious cardiac arrhythmia requiring medication. Patients with chronic,
rate-controlled atrial fibrillation are eligible. History of stroke or transient
ischemic attack ≤6 months prior to beginning treatment.

- Any prior history of hypertensive crisis or hypertensive encephalopathy.

- Any known positive test for human immunodeficiency virus, hepatitis C virus or acute
or chronic hepatitis B infection.

- 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).

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

Determine the PFS of patients with first-line mCRC treated with maintenance axitinib after initial treatment with FOLFOX plus bevacizumab.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Johanna Bendell, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

January 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal Cancer
  • Axitinib
  • FOLFOX/Bevacizumab
  • Colorectal Neoplasms



Tennessee OncologyNashville, Tennessee  37203