NCT00006351

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SCH 66336 and gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating patients who have advanced cancer of the urinary tract.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

1.5 years

First QC Date

October 4, 2000

Last Update Submit

September 20, 2012

Conditions

Bladder CancerTransitional Cell Cancer of the Renal Pelvis and UreterUrethral Cancer

Keywords

recurrent bladder cancerstage IV bladder cancertransitional cell carcinoma of the bladderrecurrent urethral canceranterior urethral cancerposterior urethral cancerurethral cancer associated with invasive bladder cancermetastatic transitional cell cancer of the renal pelvis and ureterrecurrent transitional cell cancer of the renal pelvis and ureter

Interventions

gemcitabine hydrochlorideDRUG
lonafarnibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or unresectable primary transitional cell carcinoma of the urinary tract, including bladder, ureter, and renal pelvis * At least one measurable lesion * 20 mm or greater by conventional techniques OR * 10 mm or greater by spiral CT scan * Must have received one (and only one) prior chemotherapy regimen for advanced or metastatic disease * No clinical signs of brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN with liver metastases) Renal: * Creatinine no greater than 1.7 mg/dL Cardiovascular: * Normal cardiac function * No ischemic heart disease within the past 6 months * Normal 12 lead ECG Other: * No prior gastrectomy or any gastrointestinal disease that may impair absorption of SCH 66336 * No unstable systemic disease * No active uncontrolled infection * No psychological, familial, sociological, or geographical condition that would preclude study * No prior or concurrent other malignancy except cone biopsied carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No prior farnesyl protein transferase inhibitors or gemcitabine Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 2 weeks since prior major surgery Other: * No other concurrent anticancer agents * No other concurrent investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Nijmegen

Nijmegen, 6500, Netherlands

Location

Related Publications (1)

  • Theodore C, Geoffrois L, Vermorken JB, Caponigro F, Fiedler W, Chollet P, Ravaud A, Peters GJ, de Balincourt C, Lacombe D, Fumoleau P. Multicentre EORTC study 16997: feasibility and phase II trial of farnesyl transferase inhibitor & gemcitabine combination in salvage treatment of advanced urothelial tract cancers. Eur J Cancer. 2005 May;41(8):1150-7. doi: 10.1016/j.ejca.2005.02.015.

    PMID: 15911238RESULT

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUrethral Neoplasms

Interventions

Gemcitabinelonafarnib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUrethral Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Ronald De Wit, MD, PhD

    Daniel Den Hoed Cancer Center at Erasmus Medical Center

    STUDY CHAIR

  • Pieter H. M. de Mulder, MD, PhD

    Universitair Medisch Centrum St. Radboud - Nijmegen

    STUDY CHAIR

  • Godefridus Peters, PhD

    Free University Medical Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 4, 2000

First Posted

January 27, 2003

Study Start

June 1, 2000

Primary Completion

December 1, 2001

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

NL(1)