Sunitinib as Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Transitional Cell Cancer

• ClinicalTrials.gov Identifier: NCT00792025
• Recruitment Status: Completed
• First Posted: November 17, 2008
• Last Update Posted: May 17, 2011
• Sponsor: Institut Curie
• Information provided by: National Cancer Institute (NCI)

Study Description

Brief Summary:

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying sunitinib to see how well it works as second-line therapy in treating patients with locally advanced or metastatic transitional cell cancer.

Condition or disease	Intervention/treatment	Phase
Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter	Drug: sunitinib malate	Phase 2

Detailed Description:

OBJECTIVES:

Primary

• To determine the objective tumor response rate according to RECIST criteria in patients with locally advanced or metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate who failed or progressed after first-line chemotherapy .

Secondary

• To determine the safety of this drug.
• To determine the time to response and duration of response.
• To determine the progression-free survival and overall survival of these patients.
• To evaluate the quality of life of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks for 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Non-Randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicentre Phase II Trial to Determine the Efficacy of the Anti-Tyrosine Kinase Sunitinib (Sutent®) as Second Line Therapy in Patients With Transitional Cell Carcinoma (TCC) of the Urothelium Which Failed or Progressed After First Line Chemotherapy for Advanced or Metastatic Disease
• Study Start Date: December 2008
• Actual Primary Completion Date: May 2011

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Objective response as assessed by RECIST criteria

Secondary Outcome Measures :

1. Progression-free survival
2. Overall survival
3. Time to response and duration of response
4. Safety
5. Quality of life

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell cancer of the urothelium

  • Advanced or metastatic disease
  • Disease failed or progressed after first-line chemotherapy
• At least 1 non-irradiated measurable lesion assessed by CT scan or MRI according to RECIST
• No progressive brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 8g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in presence of liver metastases)
• Creatinine clearance ≥ 40 mL/min
• PTT and INR ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during study treatment
• No uncontrolled high BP, defined as > 150/100 mm Hg despite treatment
• No diagnosis of a second malignancy within the past 5 years, except for basal cell or squamous cell carcinoma of the skin, incidental PT2 prostate cancer found on radical cystoprostatectomy material, or carcinoma in situ of the cervix, that has been adequately treated with no evidence of recurrence in the past 12 months

• None of the following within the past 12 months:

  • Myocardial infarction
  • Severe/unstable angina pectoris
  • Coronary artery bypass graft
  • Symptomatic congestive heart failure
  • Cerebrovascular accident
  • Transient ischemic attack
  • Pulmonary embolism
• At least 6 months since deep vein thrombosis
• No NCI CTCAE grade 3 hemorrhage within the past 4 weeks
• No pre-existing neuropathy ≥ NCI CTCAE grade 2
• No history of interstitial pneumonitis or pulmonary fibrosis
• No ongoing cardiac arrhythmias ≥ NCI CTCAE grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval (> 450 msec for males or > 470 msec for females)
• No ongoing active infection
• No patients deprived of liberty or who are under supervision (including a trusteeship)
• No psychological, familial, sociological, or geographic condition potentially hampering compliance with study treatment and follow-up
• Patients must be affiliated to a social security system

PRIOR CONCURRENT THERAPY:

• Prior platinum-based therapy allowed
• No prior sunitinib malate
• No prior radiotherapy to ≥ 25% of marrow producing area
• Prior neoadjuvant or adjuvant chemotherapy allowed

• More than 2 weeks since prior and no concurrent oral anticoagulant agents at therapeutic doses

  • Low molecular weight heparin allowed
• At least 30 days since prior chemotherapy or radiotherapy and recovered
• No other concurrent anticancer treatment, including experimental agents, or participation in another investigational trial

Contacts and Locations

Locations

France

Centre Rene Huguenin

Saint Cloud, France, 92211

Hopital Foch

Suresnes, France, 92151

Sponsors and Collaborators

Institut Curie

Investigators

• Principal Investigator: Christine Theodore, MD; Hopital Foch

More Information

• ClinicalTrials.gov Identifier: NCT00792025
• Other Study ID Numbers: CDR0000618219; FRE-CRH-06-374-M; FRE CRH-VESSU; INCA-RECF0845; EUDRACT-2008-001004-22; PFIZER-FRE-CRH-06/374/M
• First Posted: November 17, 2008
• Last Update Posted: May 17, 2011
• Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):

metastatic transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter; stage III bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; recurrent bladder cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Diseases; Ureteral Diseases; Sunitinib; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action