Trial of Maintenance SU011248 Versus Placebo Post Chemotherapy Patients With Advanced Urothelial Carcinoma

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01225848
First received: April 28, 2010
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

This is a randomized Blinded Phase II trial of Maintenance SU011248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma.


Condition Intervention Phase
Patients With Advanced Urothelial Carcinoma.
Drug: SU011248
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Randomized Blinded Phase II Trial of Maintenance SU011248 Versus Placebo Post Chemotherapy Patients With Advanced Urothelial Carcinoma

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Progression Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To compare the progression rate associated with SU011248 versus Placebo in patients with advanced urothelial carinoma who have achieved at least stable disease following combination chemotherapy


Estimated Enrollment: 10
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SU011248
    blinded-SU011248 or Placebo given at 50 mg/day as single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks. Suty drug will be orally self administered once daily without regard to meals beginning on Day 1 of the study.
Detailed Description:

The primary objective of this study is to compare the progression rate associated with SU011248 versus Placebo in patients with advanced urothelial carcinoma who have achieved at least stable disease following combination chemotherapy. Secondary objectives of the trial: We will explore the safety of SU011248, assess the objective response rate associated with SU011248 therapy in patients with stable disease after chemotherapy, and assess the median survival in patients with advanced urothelial carcinoma treated with SU011248 or placebo following chemotherapy. Correlative objectives of trial: To correlate changes in VEGF and sVEGFR-2 levels with clinical response in patients with advanced urothelial carcinoma. Tertiary objective of trial: Determine response and progression rates to SU011248 in patients crossed over to treatment after placebo.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic/cytologic diagnosis of urothelial carcinoma (tranisitional cell carcinoma either pure or mixed histology).
  • All patients must have received four - six cylces of standard first line chemotherapy (see appendix A for suggested combinations) for treatment of locally recurrent or metastatic disease and must have achieved stable disease (SD), partial response (PR), or complete response (CR) to this chemotherapy.
  • Patient must be registered within on month (or the next business day if falls on a weekend or holiday) of scans demonstrating stable disease or better and no more than 42 days after receiving the last standard chemotherapy dose.
  • patients may have received previous adjuvant or neoadjuvant therapy.
  • No prior antiangiogenic therapy for this stage of the disease.
  • An ECOG performance status of 0-2 and a life expectancy of greater than 6 months.
  • If patients received radiation therapy, they must have recovered from side effects before registration to study.
  • No prior malignancy is allowed, except for adequately treated basal cell (or squamouscell) skin cancer or in situ carcinoma of any site or other adequately treated malignancy for which the patient is currently disease free for at least one year. Patients with prostate cancer diagnosed at the time of cystectomy who have an undetectable PSA without hormonal therapy will be eligible.
  • Timing guidelines for pre-study labs and measurements:
  • All pre-study labs required for determination of eligibility are to be completed within 14 days prior to registration.
  • X-rays and/or scans used for tumor measurement to determine disease status EKG, and MUGA are to be completed within one month prior to registration.
  • Patients must have adequate organ and marrow function as defined below obtained within 14 days from registration.
  • All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria

  • Major surgery within 4 weeks of starting the study treatment.
  • NCI CTCAE grade 3 hemorrhage or higher within 4 weeks of starting the study treatment.
  • History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
  • Known HIV - positive patients may not participate. This is to avoid additional complications that immune supression and HIV infection may cause due tothe intense nature of the chemotherapy in this trial.
  • Any of the following within the 6 months prior to the study drug administration:myocardial infraction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischemic attack, pulmonary embolism.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade >2.
  • Patients with history of who are suspected to have CHF can be included as long as they are asymptomatic and have an ejection fraction that is equal to or above the institutional lower limit of normal by baseline MUGA.
  • QTc interval> 500 msec on baseline EKG.
  • Hypertension that cannot be controlled by medications (>150/11 mm Hg despite optimal medical therapy).
  • Patients with pre-existing thyroid function abnormalities that can not be controlled medically.
  • Patients may not have unresolved bacterial infection.
  • Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
  • Pregnancy or brestfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgement of the principal investigator or a designated associate.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormally that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgement of the investigator would make the subject inappropriate for entry into thid study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225848

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
University of Michigan
Investigators
Principal Investigator: David Vaughn, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: David Vaughn, MD, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01225848     History of Changes
Other Study ID Numbers: UPCC 14809
Study First Received: April 28, 2010
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014