SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00020774

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of SCH 66336 with or without gemcitabine followed by surgery with that of surgery alone in treating patients who have primary liver cancer.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer	Drug: gemcitabine hydrochloride Drug: lonafarnib Procedure: conventional surgery	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 1998

Actual Primary Completion Date :

Jan 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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