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UAB 0001
Phase
II and Pharmacokinetic Trial of Rebeccamycin Analog in
Hepatobiliary Cancers
SPONSOR:
National Cancer Institute (NCI)
PRINCIPAL
INVESTIGATOR: James Posey, M.D.
OBJECTIVES
The primary
objectives of this trial are:
- To determine
the response rate to rebeccamycin in advanced hepatobiliary
cancer.
- To observe
the toxicity associated with this regimen among patients
with advanced hepatobiliary cancer.
- To measure
rebeccamycin analog pharmacokinetics.
A secondary objective
is:
- To evaluate
the survival in these patients.
PATIENT
SELECTION
Inclusion
Criteria
- Patients with
advanced hepatobiliary carcinoma (hepatocellular carcinoma,
gall bladder cancer, cholangiocarcinoma, carcinoma of
the ampulla) not amenable to conventional surgical approach
will be eligible.
- Patients must
have an ECOG perfomance status of 0, 1, or 2.
- Patients must
have a life expectancy of at least 12 weeks.
- Patients must
have adequate hematologic, renal, and metabolic function
defined as follows: WBC at least 3000/µL (granulocytes
at least 1500/µL); platelets at least 100,000/µL;
hemoglobin greater than 10g/dL. Patients should have a
creatinine within instutional normal range. If the creatinine
is elevated , a creatinine clearance > 60 mg/min/1.73m2
is required.
- Patients must
have measurable disease.
- Patients must
have given written informed consent.
- Sexually active
men and women must use an accepted and effective method
of contraception.
- Women of childbearing
age must have negative pregnancy test.
Exclusion
Criteria
- No prior chemotherapy
will be allowed.
- Patients with
NYHA Classification III or IV heart disease are ineligible.
- Patients with
known brain metastases should be excluded from this clinical
trial because of their prognosis and because they often
develop progressive neurological dysfunction that would
confound the evaluation of neurological and other adverse
events.
- Patients who
are pregnant or lactating. Rebeccamycin analog is a DNA
intercalator and can be teratogenic to the fetus.
- Because patients
with immune deficiency are at increased risk of lethal
infections when treated with marrow-suppressive therapy,
HIV-positive patients receiving combination antiviral
therapy are excluded from the study because of possible
pharmacokinetics interactions with rebeccamycin analog.
- Patients with
a bilirubin > 3mg/dL are ineligible for this
trial.
ADDITIONAL
INFORMATION
For more information,
contact Michelle Mulkey, RN at (205) 975-9481 or page through
the UAB Paging Operator at (205) 934-3411, Pager #7123.
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