Trial of Maintenance SU011248 Versus Placebo Post Chemotherapy Patients With Advanced Urothelial Carcinoma
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ClinicalTrials.gov Identifier: NCT01225848
Recruitment Status :
First Posted : October 21, 2010
Last Update Posted : January 26, 2016
Abramson Cancer Center of the University of Pennsylvania
University of Michigan
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
This is a randomized Blinded Phase II trial of Maintenance SU011248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma.
Condition or disease
Patients With Advanced Urothelial Carcinoma.
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.
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.