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Randomized Ph II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combination With IV Systemic Chemo With/Without Bevacizumab (mAB to Vascular Endothelial Growth Factor-A) in Patients With Resected Hepatic Metastases From Colorectal Cancer

Phase 2
19 Years
Open (Enrolling)
Hepatic Metastases, Colon Cancer, Rectal Cancer

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Trial Information

Randomized Ph II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combination With IV Systemic Chemo With/Without Bevacizumab (mAB to Vascular Endothelial Growth Factor-A) in Patients With Resected Hepatic Metastases From Colorectal Cancer

Inclusion Criteria:

- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver
with no clinical or radiographic evidence of extrahepatic disease. Confirmation of
diagnosis must be performed at MSKCC.

- Potentially completely resectable hepatic metastases without current evidence of
other metastatic disease.

- Abdominal and pelvic CT scans and chest CT or x-ray within 6 weeks prior to
registration. (MRI of abdomen may be substituted for CT of abdomen.)

- Lab values within 14 days prior to registration:

- WBC ≥ 3.0 K/uL

- ANC > 1.5 K/uL

- Platelets ≥ 75 K/uL

- Total bilirubin < 1.5 mg/dL

- INR < 1.5

- Creatinine < 2.0 mg/dL

- HGB ≥ 9 gm/dL

- Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration
to this study. [Note: no chemotherapy to be given after resection of liver lesions
prior to treatment on this study.]

- KPS ≥ 70%

- Signed informed consent

- Patient age must be >18

Exclusion Criteria:

- Prior radiation to the liver. (Prior radiation therapy to the pelvis is acceptable if
completed at least 4 weeks prior to registration.)

- Active infection, ascites, hepatic encephalopathy.

- Prior treatment with HAI FUDR.

- Female patients who are pregnant or lactating.

- Subjects discovered to have ≥1+ proteinuria at baseline will undergo a 24-hour urine
collection, which must be an adequate collection and must demonstrate <1 g of
protein/24 hours to allow participation in this study.

- Patients may not be receiving any other investigational agents

- Patients with known brain metastases that would confound the evaluation of neurologic
and other adverse events will be excluded. Patients with history of primary CNS
tumors, seizures not well-controlled with standard medical therapy, or history of
stroke will also be excluded.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to bevacizumab.

- Serious or non-healing active wound, ulcer, or bone fracture

- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to Day 1 of protocol treatment. (Surgery performed to resect metastatic lesions
and place pump will not exclude patient from protocol; Day 1 of protocol treatment
will take place no sooner than 28 days after surgery.)

- Current or recent use of a thrombolytic agent.

- Chronic daily treatment with aspirin (> 325 mg/d) or nonsteroidal anti-inflammatory
medications known to inhibit the platelet function.

- Presence of bleeding diathesis or coagulopathy.

- History of serious systemic disease, including myocardial infarction within the last
12 months, uncontrolled hypertension (blood pressure of > 160/110 mmHg on
medication), unstable angina within the last 12 months, New York Heart Association
(NYHA) Grade II or greater congestive heart failure (see Appendix C), unstable
symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia,
i. e. atrial fibrillation or paroxysmal supraventricular tachycardia are eligible),
or peripheral vascular disease (Grade II or greater).

- Patients with a history of stroke or transient ischemic attack.

- Presence of central nervous system or brain metastases.

- Patients who have a diagnosis of Gilbert's disease.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine whether the addition of concurrent intravenous bevacizumab to HAI plus systemic chemotherapy increases the time to progression in patients with completely resected hepatic metastases from colorectal cancer

Outcome Time Frame:

7.5 months

Safety Issue:


Principal Investigator

Nancy Kemeny, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2004

Completion Date:

November 2013

Related Keywords:

  • Hepatic Metastases
  • Colon Cancer
  • Rectal Cancer
  • Colon
  • Rectal
  • 04-086
  • Adjuvant postoperative chemo for CLM
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms



Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Rockville Centre, New York  11570
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memorial Sloan-Kettering Cancer Center 1275 York Avenue New York, New York  10021
Memoral Sloan Kettering Cancer Center at Phelps Sleepy Hollow, New York  10591