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Completed

NCT Number: NCT00578526

SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.

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Key information

Conditions

Urothelial Cancer Adult Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

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About this study

The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the toxicities and tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are intolerant to cisplatin-based chemotherapy.

The primary endpoint of the study is to compare progression free survival at 4 months in patients who received SU011248 plus BSC versus patients who received placebo plus BSC

The secondary endpoint is to compare the objective response rate and duration of response in patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to describe the QOL and safety profile of SU011248 when compared to placebo and to describe the overall survival in patients who received SU011248 plus BSC versus patients who received placebo plus BSC

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract
  • Mixed histology with predominant TCC allowed.
  • Failed, intolerant or ineligible for cisplatin based chemo
  • Measurable Disease (RECIST)Not previously irradiated.
  • Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0)
  • No weight loss >/- 10% within 28 days of day 0
  • Adequate Organ Function

Exclusion criteria

  • Adenocarcinoma, squamous carcinoma or other histology without any components of transitional carcinoma.
  • Small cell histology
  • More than one previous systemic chemo
  • Excised metastases without remaining measureable disease
  • Prior therapy with angiogenesis inhibitors

Treatment and study plan

SU011248

Drug

50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression

Other names: Sutent, Sunitinib

Placebo

Drug

50 mg capsule OD PO for 28 days then 14 days rest until disease progression

Primary outcomes

  1. Progression Free Survival

    Time frame: 4 months

Secondary outcomes

  1. objective response rate

    Time frame: Study Duration

  2. duration of response

    Time frame: study duration

  3. Change in health-related quality of life

    Time frame: Study Duration

  4. Number of participants that develop an adverse event to treatment.

    Time frame: Study Duration

  5. Overall Survival

    Time frame: Study Duration

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Collaborators

  • Pfizer

Registry information

Official study title

A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy

Acronym: SPRUCE

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2007
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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