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

July 29, 2020 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Study Chair: Rafael G. Amado, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Primary Completion (ACTUAL)

January 1, 2003

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

April 12, 2004

First Posted (ESTIMATE)

April 13, 2004

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068712
  • UCLA-0002038
  • NCI-G01-1958

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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