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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00020774
First Posted: April 13, 2004
Last Update Posted: October 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  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 2

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:


Further study details as provided by Jonsson Comprehensive Cancer Center:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020774


Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Rafael G. Amado, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00020774     History of Changes
Other Study ID Numbers: CDR0000068712
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-0002038
NCI-G01-1958
First Submitted: July 11, 2001
First Posted: April 13, 2004
Last Update Posted: October 30, 2015
Last Verified: July 2012

Keywords provided by Jonsson Comprehensive Cancer Center:
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
Lonafarnib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs