Phase I/II Escalating ADR/5-FU Integrated with Isotopic Immunoglobulin Following Radiotherapy plus ADR/5-FU for Liver Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase ITreatmentCompletedunder 75NCIRTOG-8301


I.  Provide the necessary data to determine the maximum safe dose of 
adriamycin and 5-fluorouracil that can be combined with I-131 antiferritin IgG 
(given 30 mCi on day 0 and 20 mCi on day 5).
II.  Determine whether 20 mCi I-131 anti-AFP plus 30 mCi antiferritin 
increases tumor dose deposition and offers advantage in tumor effective 
half-life and dose deposition over I-131 antiferritin alone.
III.  Combine the radiolabeled preparation considered best (on dosimetric 
grounds) with escalating doses of adriamycin and 5-fluorouracil.
IV.  Determine the best combination of adriamycin and 5-fluorouracil plus 
I-131 labeled antibody for Phase II trial in AFP and non-AFP hepatomas.
V.  Complete Phase II trials using physical exam and CT tumor volume 
reconstruction to determine the remission rate, duration of remission, and 

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients less than 75 years of age 
with measurable or evaluable (on CT scan), histologically confirmed primary 
hepatic malignancy.  Patients must have a Karnofsky performance status of 
greater than 30 prior to entry and a performance status of greater than 60 
prior to immunoglobulin therapy.  Bone marrow, hepatic, renal, and cardiac 
functions must be adequate; patients must be cleared of active infection.  
There may be no chemotherapy, major surgery, partial hepatectomy, or large 
field radiation therapy during the 28 days prior to entry.  Protocol treatment 
may begin 2 weeks following exploratory laparotomy if recovery is uneventful.

Expected Enrollment

Approximately 20 patients with AFP hepatoma and 15 patients with non-AFP 
disease are required for the Phase I portion of the study; 15-20 patients in 
each disease category will be required for the Phase II portion.


Nonrandomized study.  Patients with non-AFP hepatoma enter Regimen A; those 
with AFP hepatoma enter Regimen B.
Regimen A:  Radiotherapy plus 2-Drug Chemotherapy plus Isotopic Therapy.  
Tumor irradiation using cobalt teletherapy or supervoltage equipment (2 MeV or 
greater); plus Adriamycin, ADR, NSC-123127; 5-Fluorouracil, 5-FU, NSC-19893; 
plus I-131 Antiferritin IgG.
Regimen B:  Radiotherapy plus 2-Drug Chemotherapy plus Isotopic Therapy.  
Tumor irradiation; plus ADR; 5-FU; plus I-131 Antiferritin IgG; plus I-131 
anti-alpha fetoprotein, I-131 anti-AFP.

Published Results

Stillwagon GB, Order SE, Klein JL, et al.: Multi-modality treatment of primary nonresectable intrahepatic cholangiocarcinoma with 131I anti-CEA--a Radiation Therapy Oncology Group Study. Int J Radiat Oncol Biol Phys 13 (5): 687-95, 1987.[PUBMED Abstract]

Related Publications

Ettinger DS, Leichner PK, Siegelman SS, et al.: Computed tomography assisted volumetric analysis of primary liver tumor as a measure of response to therapy. Am J Clin Oncol 8 (5): 413-8, 1985.[PUBMED Abstract]

Leichner PK, Klein JL, Fishman EK, et al.: Comparative tumor dose from 131I-labeled polyclonal anti-ferritin, anti-AFP, and anti-CEA in primary liver cancers. Cancer Drug Deliv 1 (4): 321-8, 1984 Fall.[PUBMED Abstract]

Epstein BE, Pajak TF, Haulk TL, et al.: Metastatic nonresectable fibrolamellar hepatoma: prognostic features and natural history. Am J Clin Oncol 22 (1): 22-8, 1999.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Stanley Order, MD, ScD, FACR, Protocol chair
Ph: 516-222-5190

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.