NCT00020774

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

April 13, 2004

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2012

Enrollment Period

4.3 years

First QC Date

July 11, 2001

Last Update Submit

July 29, 2020

Conditions

Liver Cancer

Keywords

localized resectable adult primary liver cancerrecurrent adult primary liver canceradult primary hepatocellular carcinomaadult primary cholangiocellular carcinoma

Interventions

gemcitabine hydrochlorideDRUG
lonafarnibDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed resectable primary hepatocellular carcinoma or cholangiocarcinoma
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Gemcitabinelonafarnib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Rafael G. Amado, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2001

First Posted

April 13, 2004

Study Start

October 1, 1998

Primary Completion

January 1, 2003

Last Updated

July 31, 2020

Record last verified: 2012-07