NCT00006026

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic cancer of the urinary tract.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Geographic Reach
7 countries

11 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

May 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

March 16, 2004

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

1.4 years

First QC Date

July 5, 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 bladdersquamous cell carcinoma of the bladderadenocarcinoma of the bladderrecurrent urethral canceranterior urethral cancerposterior urethral cancerurethral cancer associated with invasive bladder cancermetastatic transitional cell cancer of the renal pelvis and ureterregional transitional cell cancer of the renal pelvis and ureterrecurrent transitional cell cancer of the renal pelvis and ureter

Interventions

rubitecanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable primary carcinoma of the urinary tract including bladder, ureter, and renal pelvis Transitional cell carcinoma OR Mixed cell carcinoma OR Squamous cell carcinoma OR Adenocarcinoma Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: 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 in case of hepatic metastases) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: Normal cardiac function No ischemic disease in past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancies except cone biopsied carcinoma of the cervix or adequately treated basal or squamous cell skin carcinoma No concurrent unstable systemic disease or active uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Must have received 1 prior chemotherapy regimen for advanced or metastatic disease At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 14 days 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 (11)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, 21079, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Azienda Ospedaliera di Padova

Padova (Padua), 35128, Italy

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Clinique De Genolier

Genolier, Ch-1272, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUrethral Neoplasms

Interventions

rubitecan

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pierre Fumoleau, MD, PhD

    Centre Georges Francois Leclerc

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 5, 2000

First Posted

March 16, 2004

Study Start

May 1, 2000

Primary Completion

October 1, 2001

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

ES(1)BE(1)FR(4)CH(2)NL(1)IT(1)IL(1)