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A Phase IB Clinical Study Of The Farnesyltransferase Inhibitor SCH 66336 And Gemcitabine In Patients With Resectable Primary Liver Neoplasms


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

A Phase IB Clinical Study Of The Farnesyltransferase Inhibitor SCH 66336 And Gemcitabine In Patients With Resectable Primary Liver Neoplasms


OBJECTIVES: I. Determine the biologic activity and toxicity of neoadjuvant SCH 66336 with or
without gemcitabine followed by surgical resection vs surgical resection alone in patients
with resectable primary liver cancer.

OUTLINE: This is a randomized, open-label study. Patients are randomized to one of three
treatment arms. Arm I: Patients receive neoadjuvant oral SCH 66336 twice daily for 14 days
followed by surgical resection. Arm II: Patients receive neoadjuvant oral SCH 66336 twice
daily for 14 days and gemcitabine IV over 30 minutes once weekly for 2 weeks followed by
surgical resection. Arm III: Patients undergo surgical resection. Patients receive no
neoadjuvant therapy prior to resection.

PROJECTED ACCRUAL: Approximately 30 patients (10 per treatment arm) will be accrued for this
study.


Inclusion Criteria:



- Histologically or cytologically confirmed resectable primary hepatocellular carcinoma
or cholangiocarcinoma

- 18 and over

- Karnofsky 70-100%

- Hematopoietic: Absolute neutrophil count greater than 1,500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin at least 9 g/dL Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT or SGPT no greater
than 5 times ULN

- Albumin at least 2.5 g/dL INR less than 1.3 Renal:

- Creatinine no greater than 1.5 mg/dL

- Cardiovascular: QTc prolongation no greater than 440 msec Other:

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

- At least 6 weeks since prior radiotherapy and recovered

- At least 6 weeks since prior surgery and recovered

- At least 6 weeks since prior systemic therapy and recovered

Exclusion Criteria:

- metastatic disease outside of the liver

- pregnant or nursing

- malabsorption or other gastrointestinal (GI) condition that would preclude ability to
take oral medication and/or GI absorption (e.g., partial small bowel obstruction)

- non-malignant systemic disease that would preclude study

- active uncontrolled infection No grade II nausea or grade I vomiting despite
antiemetic medication

- concurrent immunotherapy Chemotherapy: No other concurrent chemotherapy

- concurrent hormonal therapy including estrogen therapy

- concurrent oral contraceptives or other hormonal methods Concurrent megestrol acetate
allowed

- concurrent corticosteroids (except for nausea/vomiting during gemcitabine
administration)

- concurrent CYP3A4 inhibitors or inducers including: Azoles (e.g., itraconazole,
clotrimazole, fluconazole, or ketoconazole) Macrolide antibiotics (e.g.,
azithromycin, clarithromycin, or erythromycin) Cyclosporine Grapefruit Antiepileptic
medication (e.g., phenytoin, carbamazepine, or phenobarbital) Antibiotics for
tuberculosis (e.g., rifampin or isoniazid)

- concurrent HIV protease inhibitors (e.g., amprenavir, ritonavir, or saquinavir
mesylate)

- concurrent cisapride

- other concurrent investigational therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Rafael G. Amado, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068712

NCT ID:

NCT00020774

Start Date:

October 1998

Completion Date:

Related Keywords:

  • Liver Cancer
  • localized resectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • adult primary cholangiocellular carcinoma
  • Liver Neoplasms

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