UAB 0001

Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers

Sponsor: National Cancer Institute (NCI)

Prinicipal Investigator: James Posey, M.D.

Objectives:

The primary objectives of this trial are:

1. To determine the response rate to rebeccamycin in advanced hepatobiliary cancer.



2. To observe the toxicity associated with this regimen among patients with advanced hepatobiliary cancer.



3. To measure rebeccamycin analog pharmacokinetics.

A secondary objective is:

1. To evaluate the survival in these patients.

Patient Selection

Inclusion Criteria

1. Patients with advanced hepatobiliary carcinoma (hepatocellular carcinoma, gall bladder cancer, cholangiocarcinoma, carcinoma of the ampulla) not amenable to conventional surgical approach will be eligible.



2. Patients must have an ECOG perfomance status of 0, 1, or 2.



3. Patients must have a life expectancy of at least 12 weeks.



4. 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.



5. Patients must have measurable disease.



6. Patients must have given written informed consent.



7. Sexually active men and women must use an accepted and effective method of contraception.



8. Women of childbearing age must have negative pregnancy test.

Exclusion Criteria

1. No prior chemotherapy will be allowed.



2. Patients with NYHA Classification III or IV heart disease are ineligible.



3. 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.



4. Patients who are pregnant or lactating. Rebeccamycin analog is a DNA intercalator and can be teratogenic to the fetus.



5. 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.



6. 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.