Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01437488|
Recruitment Status : Completed
First Posted : September 21, 2011
Results First Posted : August 9, 2017
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Drug: Cabazitaxel Drug: Neulasta Procedure: CT Scan Biological: Blood Draw||Phase 2|
This is a single-arm, open-label study, meaning all patients will be treated in the same fashion with the investigational agent. Scans will be performed every 3 cycles of treatment, and patients will be withdrawn from study in the event of progression or drug intolerance as defined within the protocol.
Treatment will be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.
The length of each cycle is 21 days. For the first cycle of treatment, cabazitaxel will be dosed at 20 mg/m2. During cycle 1, complete blood counts will be performed on days 8 and 15, and dosing on Day 1 cycle 2 will depend upon the nadir counts on those days. If, on toxicity assessment on day 1 of cycle 2, the patient has no residual >grade 2 toxicity, and all other laboratory parameters are within acceptable limits (see below),at the investigator's discretion the dose can be escalated to 25 mg/m2. 25 mg/m2 is the FDA (Food and Drug Administration)-approved dose for prostate cancer. Neulasta will be given with each dose of cabazitaxel to decrease the risk of febrile neutropenic complication.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy|
|Actual Study Start Date :||February 16, 2012|
|Actual Primary Completion Date :||August 4, 2014|
|Actual Study Completion Date :||March 30, 2017|
Cabazitaxel following platinum-based chemotherapy
Other Names:Drug: Neulasta
6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days
Other Name: PegfilgrastimProcedure: CT Scan
CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)
Other Name: X-ray computed tomographyBiological: Blood Draw
Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment
Other Name: Venipuncture
- Overall Response Rate [ Time Frame: Every 3 cycles or 63 days ]To determine the overall response rate of patients who have disease response while on treatment with Cabazitaxel. CT scan will be used to measure tumor pre-treatment and then every 3 cycles (every 63 days)
- Overall Survival [ Time Frame: At 12 months ]To determine the percentage of patients alive at 12 months from trial entry. Overall survival will be measured from date of randomization to date of death due to any cause.
- Progression Free Survival [ Time Frame: Every 3 cycles or 63 days ]To determine the progression free survival (PFS) of patients with advanced or recurrent urothelial carcinoma who have previously been treated with a platinum based regimen while on treatment with cabazitaxel. Defined as a 20% increase in the largest diameter of the largest lesion by CT scan.
- Number of Participants Who Tolerated Cabazitaxel [ Time Frame: Up to 30 days after completion of study treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437488
|United States, Maryland|
|National Cancer Institute|
|Bethesda, Maryland, United States, 20892|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Jean Hoffman-Censits, MD||Thomas Jefferson University|