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

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00020774

Purpose

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	Intervention	Phase
Liver Cancer	Drug: gemcitabine hydrochloride Drug: lonafarnib Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Lonafarnib

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Enrollment:	0
Study Start Date:	October 1998
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020774

Sponsors and Collaborators

University of California, Los Angeles

National Cancer Institute (NCI)

Investigators

Study Chair:

Rafael G. Amado, MD

Jonsson Comprehensive Cancer Center

More Information

No publications provided

Responsible Party:	Rafael Amado, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00020774 History of Changes
Other Study ID Numbers:	CDR0000068712, P30CA016042, UCLA-0002038, NCI-G01-1958
Study First Received:	July 11, 2001
Last Updated:	April 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

localized resectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma
adult primary cholangiocellular carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012