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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 is ongoing, but not recruiting participants.
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: Jonsson Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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: 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 National Cancer Institute (NCI):

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed resectable primary hepatocellular carcinoma or cholangiocarcinoma No metastatic disease outside of the liver

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified 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: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No malabsorption or other gastrointestinal (GI) condition that would preclude ability to take oral medication and/or GI absorption (e.g., partial small bowel obstruction) No non-malignant systemic disease that would preclude study No active uncontrolled infection No grade II nausea or grade I vomiting despite antiemetic medication

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy including estrogen therapy No concurrent oral contraceptives or other hormonal methods Concurrent megestrol acetate allowed No concurrent corticosteroids (except for nausea/vomiting during gemcitabine administration) Radiotherapy: At least 6 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 6 weeks since prior surgery and recovered Other: At least 6 weeks since prior systemic therapy and recovered No 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) No concurrent HIV protease inhibitors (e.g., amprenavir, ritonavir, or saquinavir mesylate) No concurrent cisapride No other concurrent investigational therapy

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

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Rafael G. Amado, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068712, UCLA-0002038, NCI-G01-1958
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00020774     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized resectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma
adult primary cholangiocellular carcinoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Liver Diseases
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Gemcitabine

ClinicalTrials.gov processed this record on November 27, 2009