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A Phase I/II Trial of Radioimmunotherapy (Y-90 cT84.66), Gemcitabine and Hepatic Arterial Infusion of Fudr for Metastatic Colorectal Carcinoma to the Liver

Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

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Trial Information

A Phase I/II Trial of Radioimmunotherapy (Y-90 cT84.66), Gemcitabine and Hepatic Arterial Infusion of Fudr for Metastatic Colorectal Carcinoma to the Liver


I. To determine the maximum tolerated dose (MTD) and associated toxicities of concurrent
hepatic arterial infusion (HAI) fluorodeoxypyrimidine (FUdR)/Decadron and intravenous
gemcitabine combined with intravenous yttrium-90 (^90Y) chimeric T84.66 (cT84.66) in
colorectal cancer patients after hepatic resection or maximum surgical debulking (to < 3 cm)
of liver metastases.

II. To study the feasibility and toxicities of such adjuvant therapy following resection
and/or ablation of liver metastases.

III. To evaluate the biodistribution, clearance and metabolism of ^90Y and ^111In
(indium-iii) chimeric T84.66 administered intravenously.

IV. To estimate radiation doses to whole body, normal organs, and tumor through serial
nuclear imaging.

V. To correlate proteomic profiles pre and post-therapy with toxicities and anti-tumor

OUTLINE: This is a phase I, dose-escalation study of floxuridine followed by a phase II

Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 and
gemcitabine hydrochloride IV over 30 minutes on days 9 and 11. Patients also receive yttrium
Y 90 anti-CEA monoclonal antibody cT84.66 IV over 25 minutes on day 9. Treatment repeats
every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable

Patients may receive an additional course of floxuridine in combination with systemic
therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 3 and 6 months.

Inclusion Criteria


- Patients must have a Karnofsky performance status of >= 60%; this must be met
pre-surgery and pre-study therapy

- Patients must have histological confirmation of colorectal carcinoma and present with
potentially resectable or abatable metachronous or synchronous hepatic metastases

- Patients must have colorectal tumors that produce CEA as documented by either
immunohistochemistry or by an elevated serum CEA

- Prior radiotherapy, immunotherapy, or chemotherapy must have been completed at least
four weeks prior to start of FUdR/RIT therapy on this study (6 weeks if mitomycin-C
or nitrosoureas were part of last therapy) and patients must have recovered from all
expected side effects of the prior therapy

- Laboratory values must be met pre-surgery and pre-study therapy

- Hemoglobin > 10 gm % (patients may be transfused to reach a hemoglobin > 10 gm %)

- WBC > 4000/ul

- Absolute granulocyte count of > 1,500/mm^3

- Platelets > 150,000/ul

- Patients may have history of prior malignancy for which the patient has been
disease-free for five years with the exception of basal or squamous cell skin cancers
or carcinoma in situ of the cervix

- Patients must have no prior history of radiation therapy to the liver

- Total bilirubin < 1.5 (unless reversibly obstructed due to the metastatic tumor)

- Serum creatinine of < 2.0

- Patients must have evidence of intrahepatic metastases involving < 60% of the
functioning liver

- Patients cannot have evidence of extrahepatic disease with the following exceptions:
patients known to have a resectable "anastomotic" or local recurrence of their tumor;
patients who undergoing their initial surgery for resection of their primary
colorectal carcinoma can have potentially resectable porta hepatis and/or mesenteric
lymph node involvement in addition to liver metastases; patients who have disease
extension from the liver metastasis that can be resected en bloc (e.g., diaphragm,
kidney, and abdominal wall); patients who have minimal, potentially resectable to
less than 3 cm extrahepatic disease

- The pre-operative eligibility checklist must be completed

- If a patient has previously received murine or chimeric antibody, then serum
anti-antibody testing must be negative (This must be met pre-surgery if possible)

- Serum HIV testing and hepatitis B surface antigen and C antibody testing must be

- Women of childbearing potential must have a negative serum pregnancy test prior to
entry and while on study must be practicing an effective form of contraception (This
must be met pre-surgery and pre-study therapy)

- Patients must have resectable or abatable liver metastases as determined by the
attending surgeon

- Colorectal carcinoma must be confined to the liver except as noted above

- Patients with limited extrahepatic disease as defined (primary, lymph node, or
anastomotic recurrence) must have disease resected or debulked to less than 3 cm in
greatest dimension

- To receive study therapy, patients must be at least 3 weeks post-surgery but no more
than 16 weeks post surgery and without evidence of post-operative complications, such
as infection or poor wound healing

- Patients must have < 40% liver resected at the close of completion of the hepatic


- Patients that have received radiation therapy to greater than 50% of their bone

- Patients with any nonmalignant intercurrent illness (example cardiovascular,
pulmonary, or central nervous system disease) which is either poorly controlled with
currently available treatment or which is of such severity that the investigators
deem it unwise to enter the patient on protocol shall be ineligible

- Biopsy-proven chronic active hepatitis

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

At 2 years

Safety Issue:


Principal Investigator

Jeffrey Wong

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Liver Metastases
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms



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