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Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combination With Chemotherapy With/Without Bevacizumab for Hepatic Metastases From Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200200
Recruitment Status : Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : April 28, 2020
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to determine whether the addition of bevacizumab, to hepatic arterial therapy with floxuridine (FUDR) and dexamethasone (Dex) (regional chemotherapy), and either oxaliplatin or CPT-11, plus 5-fluorouracil and leucovorin (systemic chemotherapy) will increase disease free survival in patients who have undergone liver resection. The patient will be randomized (a computer generated decision as in the flip of a coin) to receive, or not to receive bevacizumab in addition to regional and systemic chemotherapy.

Condition or disease Intervention/treatment Phase
Hepatic Metastases Colon Cancer Rectal Cancer Drug: Bevacizumab HAI plus systemic chemotherapy Drug: HAI plus systemic chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 19, 2004
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Bevacizumab in addition to HAI plus systemic chemotherapy
Drug: Bevacizumab HAI plus systemic chemotherapy
Oxaliplatin (mg/m2) IV, over 2 hours, 5 FU (mg/m2) continuous infusion, over two days, leucovorin (mg/m2) IV, over 2 hours

Experimental: 2
HAI plus systemic chemotherapy alone
Drug: HAI plus systemic chemotherapy
Irinotecan (mg/m2) IV, over 30 minutes, 5 FU (mg/m2) continuous infusion over two days, leucovorin (mg/m2) IV, over 30 minutes

Primary Outcome Measures :
  1. 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 [ Time Frame: 7.5 months ]

Secondary Outcome Measures :
  1. To assess toxicity [ Time Frame: 7.5 months ]
  2. To determine survival [ Time Frame: 2 years ]
  3. To assess the expression pattern of VEGFR1, VEGFR2 (angiogenesis), and VEGFR3 (lymphangiogenesis) and their cognate ligands (VEGF-A, VEGF-C, VEGF-D), and correlate with patient progression and survival following [ Time Frame: 2 years ]
  4. To compare plasma levels of VEGF-A, VEGF-C, VEGF-D, and CD133+ VEGFR2+ circulating endothelial progenitors [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200200

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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Follow Up Only)
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan Kettering Cancer Commack (Follow Up Only)
Commack, New York, United States, 11725
Memoral Sloan Kettering Westchester (Follow Up Only)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau (Follow Up Only)
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Nancy Kemeny, M.D Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00200200    
Obsolete Identifiers: NCT00263848
Other Study ID Numbers: 04-086
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Adjuvant postoperative chemo for CLM
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors