NCT00077688

Brief Summary

Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2003

Typical duration 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

November 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

June 4, 2009

Status Verified

June 1, 2009

First QC Date

February 10, 2004

Last Update Submit

June 2, 2009

Conditions

Bladder NeoplasmsUreteral NeoplasmsUrethral NeoplasmsCarcinoma, Transitional Cell

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

Secondary Outcomes (4)

  • Time to treatment failure

  • Time to progression

  • Progression free survival

  • Overall survival at 2 years

Interventions

TOCOSOL PaclitaxelDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra
  • Stage IV disease
  • One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease
  • Adequate hematologic function (ANC \>/= 1500 cells/mm3 \& platelet count \>/= 100,000/mm3)
  • Serum creatinine \</= 2.0 mg/dL
  • Total bilirubin \</= 1.5 mg/dL
  • SGOT \& SGPT \</= 3 times upper limit of institutional normal values
  • PT (INR) \& PTT within institutional lab normal range
  • Karnofsky performance status of 60-100%
  • At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria
  • Signed IRB/EC approved Informed Consent
  • Life expectancy of at least 12 weeks
  • years of age or older
  • Fully recovered from any previous surgery
  • Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females)
  • +3 more criteria

You may not qualify if:

  • Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel)
  • Peripheral neuropathy NCI-CTC grade 2 or greater
  • Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug
  • An investigational agent within 4 weeks of first dose of study drug
  • Concurrent anticonvulsants known to induce P450 isoenzymes
  • Patients who are pregnant or lactating
  • A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC
  • Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC
  • Brain metastasis
  • Active bowel obstruction
  • Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Maryland Medical Center/Greenbaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUreteral NeoplasmsUrethral NeoplasmsCarcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUreteral DiseasesUrethral DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 16, 2004

Study Start

November 1, 2003

Study Completion

September 1, 2007

Last Updated

June 4, 2009

Record last verified: 2009-06

Locations

US(3)