NCT00310011

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel and cisplatin works in treating patients with advanced transitional cell cancer of the urothelium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 1998

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

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, 1998

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

7.3 years

First QC Date

March 29, 2006

Last Update Submit

August 8, 2018

Conditions

Bladder CancerTransitional Cell Cancer of the Renal Pelvis and Ureter

Keywords

metastatic transitional cell cancer of the renal pelvis and ureterrecurrent transitional cell cancer of the renal pelvis and uretertransitional cell carcinoma of the bladderregional transitional cell cancer of the renal pelvis and ureterstage IV bladder cancerrecurrent bladder cancer

Outcome Measures

Primary Outcomes (5)

  • Response

  • Response duration

  • Freedom from progression

  • Overall survival

  • Toxicity

Interventions

cisplatinDRUG
gemcitabine hydrochlorideDRUG
paclitaxelDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, or ureter) or TCC with squamous or glandular elements * No pure squamous cell carcinoma or adenocarcinoma * Disease not amenable to local curative treatment * Regional or distant metastases of TCC of the urothelium OR local/regional recurrence after cystectomy, cystoprostatectomy, nephroureterectomy, or ureterectomy * If regional metastases present alone, histological confirmation of the metastases is required * No clinically evident brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0 or 1 * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine ≤ 1.6 mg/mL * Bilirubin ≤ 1.8 mg/mL * SGOT ≤ 3 times upper limit of normal * Life expectancy \> 3 months * No known sensitivity to E. coli-derived products * No other prior or concurrent malignancy except active/inactive nonmelanoma skin cancer, adequately treated stage I or II cancer currently in complete remission, or observation-only early-stage prostate cancer * No other serious medical illness that would limit survival to \< 3 months * No psychiatric condition that would limit compliance with study requirements * No active uncontrolled bacterial, viral, or fungal infection unless corrected or controlled * No hemorrhagic disorder * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior systemic chemotherapy regimen * Prior intravesical therapy allowed * Prior definitive radiation to renal pelvis, ureter, or bladder allowed * No concurrent chemotherapy with nonstudy drugs

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

Sponsors & Collaborators

Study Sites (3)

Carolinas Hematology-Oncology Associates

Charlotte, North Carolina, 28203-4239, United States

Location

Regional Cancer Center

Greensboro, North Carolina, 27403-1199, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

CisplatinGemcitabinePaclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Frank M. Torti, MD, MPH

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2006

First Posted

April 3, 2006

Study Start

June 1, 1998

Primary Completion

October 1, 2005

Study Completion

August 1, 2009

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(3)