Trial Outcomes & Findings for Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy (NCT NCT01437488)

Last Updated: 2025-05-04

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Every 3 cycles or 63 days

Results posted on

2025-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Cabazitaxel Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days * Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion * Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) 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 durin
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabazitaxel n=14 Participants Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days * Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion * Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) 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 durin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 3 cycles or 63 days

Outcome measures

Outcome measures
Measure	Cabazitaxel n=14 Participants Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days * Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion * Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) 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 durin
Overall Response Rate	11 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cabazitaxel n=14 Participants Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days * Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion * Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) 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 durin
Overall Survival	13 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cabazitaxel n=14 Participants Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days * Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion * Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) 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 durin
Progression Free Survival	11 Participants

SECONDARY outcome

Timeframe: Up to 30 days after completion of study treatment

Outcome measures

Outcome measures
Measure	Cabazitaxel n=14 Participants Cabazitaxel following platinum-based chemotherapy Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days * Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion * Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) 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 durin
Number of Participants Who Tolerated Cabazitaxel	11 Participants

Adverse Events

Cabazitaxel

Serious events: 2 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cabazitaxel n=14 participants at risk Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days * Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion * Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) 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
Blood and lymphatic system disorders Embolic stroke	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year

Other adverse events

Other adverse events
Measure	Cabazitaxel n=14 participants at risk Cabazitaxel: - Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days * Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion * Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator Neulasta: 6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days CT Scan: CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks) 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
General disorders Fatigue	64.3% 9/14 • Number of events 10 • Every 21 days, up to 1 year
Musculoskeletal and connective tissue disorders Abdominal cramping	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Musculoskeletal and connective tissue disorders Abdominal distention	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Musculoskeletal and connective tissue disorders Abdominal Pain	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Gastrointestinal disorders Acid Reflux	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Alkalosis	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Anemia	35.7% 5/14 • Number of events 5 • Every 21 days, up to 1 year
Psychiatric disorders Anorexia	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Musculoskeletal and connective tissue disorders Back Pain	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Renal and urinary disorders Bladder Spasm	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
General disorders Bleeding Gums	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
General disorders Bloating	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Blood in Bilirubin increased	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Eye disorders Blurred Vision	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Musculoskeletal and connective tissue disorders Bone Pain	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Product Issues Cabazitaxel Infusion reaction	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
General disorders Change in Taste	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Gastrointestinal disorders Constipation	35.7% 5/14 • Number of events 5 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Creatinine Increased	21.4% 3/14 • Number of events 3 • Every 21 days, up to 1 year
Metabolism and nutrition disorders Decreased Appetite	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Gastrointestinal disorders Diarrhea	42.9% 6/14 • Number of events 6 • Every 21 days, up to 1 year
Nervous system disorders Dizziness	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Skin and subcutaneous tissue disorders Dry Skin	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Renal and urinary disorders Dysuria	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Gastrointestinal disorders Epigastric Pain	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
General disorders Fall	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Infections and infestations Fever	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Gastrointestinal disorders Flatulence	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Infections and infestations Flu-Like symptoms	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
General disorders Foot Pain	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Hematoma	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Hematuria	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Hypophosphatemia	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Cardiac disorders Hypertension	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Hypokalemia	21.4% 3/14 • Number of events 3 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Hypomagnesia	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Blood and lymphatic system disorders INR increased	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Nervous system disorders Insomnia	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Musculoskeletal and connective tissue disorders Leg pain	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
General disorders Lightheadedness	21.4% 3/14 • Number of events 3 • Every 21 days, up to 1 year
Gastrointestinal disorders Loose Stools	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Respiratory, thoracic and mediastinal disorders mild-mod Congestion	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Gastrointestinal disorders Nausea	35.7% 5/14 • Number of events 6 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Neutrophil count decreased	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Nervous system disorders Neuropathy	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
General disorders Pain in Pelvis	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Nervous system disorders Paresthesia bilateral feet	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Nervous system disorders Perioral numbness	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Nervous system disorders Peripheral Neuropathy	7.1% 1/14 • Number of events 2 • Every 21 days, up to 1 year
General disorders Pinching sensation around port	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
General disorders PTT prolonged	7.1% 1/14 • Number of events 2 • Every 21 days, up to 1 year
Hepatobiliary disorders Pyelonephritis	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Skin and subcutaneous tissue disorders Rash	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Musculoskeletal and connective tissue disorders Rib pain	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
General disorders Sacral Edema	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Respiratory, thoracic and mediastinal disorders Shortness of Breath	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Cardiac disorders Tachycardia	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Eye disorders Tearing	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Respiratory, thoracic and mediastinal disorders Throat discomfort	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Blood and lymphatic system disorders Thrombocytopenia	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Musculoskeletal and connective tissue disorders Tinnitus	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Renal and urinary disorders Urinary incontinence	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Respiratory, thoracic and mediastinal disorders URI	14.3% 2/14 • Number of events 2 • Every 21 days, up to 1 year
Renal and urinary disorders Urinary Tract Obstruction	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Eye disorders Vision changes	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Gastrointestinal disorders Vomiting	21.4% 3/14 • Number of events 3 • Every 21 days, up to 1 year
General disorders Worsening pain	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Musculoskeletal and connective tissue disorders Weakness	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year
Metabolism and nutrition disorders Weight loss	7.1% 1/14 • Number of events 1 • Every 21 days, up to 1 year

Additional Information

Dr. Jean Hoffman-Censits

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215 955-8874

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place