Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02033993

Recruitment Status : Completed

First Posted : January 13, 2014

Results First Posted : January 18, 2020

Last Update Posted : August 22, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Celgene

Information provided by (Responsible Party):

Canadian Cancer Trials Group

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Urothelial Cancer
Interventions	Drug: Nab-Paclitaxel Drug: Paclitaxel
Enrollment	199

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	Nab-Paclitaxel - 260mg/m2: q21 days...	Paclitaxel - 175mg/m2: q21 days ...
Arm/Group Description	Nab-Paclitaxel - 260mg/m2: q21 days Nab-Paclitaxel	Paclitaxel - 175mg/m2: q21 days Paclitaxel
Period Title: Overall Study
Started	99	100
Completed	96	91
Not Completed	3	9

Baseline Characteristics

Arm/Group Title		Arm 1	Arm 2	Total
Arm/Group Description		Nab-Paclitaxel - 260mg/m2: q21 days...	Paclitaxel - 175mg/m2: q21 days ...	Total of all reporting groups
Arm/Group Description		Nab-Paclitaxel - 260mg/m2: q21 days Nab-Paclitaxel	Paclitaxel - 175mg/m2: q21 days Paclitaxel	Total of all reporting groups
Overall Number of Baseline Participants		99	100	199
Baseline Analysis Population Description		...
Baseline Analysis Population Description		ITT
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	99 participants	100 participants	199 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	38 38.4%	43 43.0%	81 40.7%
	>=65 years	61 61.6%	57 57.0%	118 59.3%
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	99 participants	100 participants	199 participants
		67 (24 to 88)	68 (35 to 84)	67 (24 to 88)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	99 participants	100 participants	199 participants
	Female	29 29.3%	26 26.0%	55 27.6%
	Male	70 70.7%	74 74.0%	144 72.4%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment Measure Type: Number Unit of measure: Participants
Canada	Number Analyzed	99 participants	100 participants	199 participants
Canada		79	81	160
Australia	Number Analyzed	99 participants	100 participants	199 participants
Australia		20	19	39

Outcome Measures

1.Primary Outcome


Title	Progression-Free Survival
Description	PFS is defined as the time from randomization to the first observation...
Description	PFS is defined as the time from randomization to the first observation of disease progression or death due to any cause.
Time Frame	42 months

Outcome Measure Data

Analysis Population Description

ITT population.


Arm/Group Title	Arm 1	Arm 2
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days...	Paclitaxel - 175mg/m2: q21 days ...
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days Nab-Paclitaxel	Paclitaxel - 175mg/m2: q21 days Paclitaxel
Overall Number of Participants Analyzed	99	100
Median (90% Confidence Interval) Unit of Measure: Months
	3.35 (2.69 to 4.30)	3.02 (2.14 to 4.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1, Arm 2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.31
	Comments	1-sided p-value
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 90% 0.68 to 1.23
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival
Description	Time from randomization to the date of death due to any causes, or cen...
Description	Time from randomization to the date of death due to any causes, or censored at last contact date.
Time Frame	42 months

Outcome Measure Data

Analysis Population Description

ITT piopulation


Arm/Group Title	Arm 1	Arm 2
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days...	Paclitaxel - 175mg/m2: q21 days ...
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days Nab-Paclitaxel	Paclitaxel - 175mg/m2: q21 days Paclitaxel
Overall Number of Participants Analyzed	99	100
Median (90% Confidence Interval) Unit of Measure: Months
	7.46 (6.44 to 8.64)	8.77 (6.11 to 10.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1, Arm 2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.40
	Comments	1-sided p-value
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 90% 0.70 to 1.30
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Clinical Benefit Rate
Description	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0...
Description	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. Clinical Benefit Rate = OR + SD > 12 weeks.
Time Frame	42 months

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	Arm 1	Arm 2
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days...	Paclitaxel - 175mg/m2: q21 days ...
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days Nab-Paclitaxel	Paclitaxel - 175mg/m2: q21 days Paclitaxel
Overall Number of Participants Analyzed	99	100
Measure Type: Number Number (90% Confidence Interval) Unit of Measure: percentage of participants
	50.5 (42.2 to 58.8)	43 (34.9 to 51.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1, Arm 2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.28
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.41
	Confidence Interval	(2-Sided) 95% 0.76 to 2.59
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Time to Response
Description	Time from the date of randomkization to the date of objective response...
Description	Time from the date of randomkization to the date of objective response according to RECIST Response Criteria was first achieved.
Time Frame	42 months

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	Arm 1	Arm 2
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days...	Paclitaxel - 175mg/m2: q21 days ...
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days Nab-Paclitaxel	Paclitaxel - 175mg/m2: q21 days Paclitaxel
Overall Number of Participants Analyzed	99	100
Median (95% Confidence Interval) Unit of Measure: Months
	17.5 (5.49 to 17.5)	35.8 (0.03 to 42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1, Arm 2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.54
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95% 0.46 to 1.51
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Health Related Quality of Life Evaluated Using EORTC-C15-Pal
Description	Quality of life will be assessed using the EORTC-C15-PAL questionnaire...
Description	Quality of life will be assessed using the EORTC-C15-PAL questionnaire plus additional study specific questions. Changes in quality of life scores while on treatment (compared to baseline scores) will be examined using descriptive analyses and inferential statistics. The primary test to compare treatment arms will be the NCIC CTG Quality of Life Committee suggested response analyses. A change score of 10 points from baseline was defined as clinically relevant. Patients were considered improved if reported a score 10-points or better than baseline at any time point in QoL assessment. Conversely, patients were considered worsened if reported a score minus 10-points or worse than baseline at any time point in QOL assessment without the above-defined improvement being observed. Patients whose scores were between 10-point changes from baseline at every QoL assessment were considered as stable.
Time Frame	42 months

Outcome Measure Data

Analysis Population Description

Patients with baseline and at least 1 after treatment evaluation.


Arm/Group Title	Arm 1	Arm 2
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days...	Paclitaxel - 175mg/m2: q21 days ...
Arm/Group Description:	Nab-Paclitaxel - 260mg/m2: q21 days Nab-Paclitaxel	Paclitaxel - 175mg/m2: q21 days Paclitaxel
Overall Number of Participants Analyzed	85	75
Measure Type: Count of Participants Unit of Measure: Participants
Improved	28 32.9%	22 29.3%
Stable	7 8.2%	13 17.3%
Worsen	50 58.8%	40 53.3%

Adverse Events

Time Frame	42 months
Adverse Event Reporting Description	The CTC version 4.0

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	Nab-Paclitaxel - 260mg/m2: q21 days...	Paclitaxel - 175mg/m2: q21 days ...
Arm/Group Description	Nab-Paclitaxel - 260mg/m2: q21 days Nab-Paclitaxel	Paclitaxel - 175mg/m2: q21 days Paclitaxel
All-Cause Mortality
	Arm 1	Arm 2
	Affected / at Risk (%)	Affected / at Risk (%)
Total	72/99 (72.73%)	67/100 (67.00%)
Serious Adverse Events Serious Adverse Events
	Arm 1	Arm 2
	Affected / at Risk (%)	Affected / at Risk (%)
Total	28/99 (28.28%)	19/100 (19.00%)
Blood and lymphatic system disorders
Febrile neutropenia ^† 1	6/99 (6.06%)	1/100 (1.00%)
Cardiac disorders
Myocardial infarction ^† 1	1/99 (1.01%)	1/100 (1.00%)
Sinus tachycardia ^† 1	0/99 (0.00%)	1/100 (1.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	2/99 (2.02%)	2/100 (2.00%)
Constipation ^† 1	1/99 (1.01%)	0/100 (0.00%)
Gastric perforation ^† 1	0/99 (0.00%)	1/100 (1.00%)
Typhlitis ^† 1	0/99 (0.00%)	1/100 (1.00%)
General disorders
Death NOS ^† 1	1/99 (1.01%)	1/100 (1.00%)
Edema limbs ^† 1	0/99 (0.00%)	1/100 (1.00%)
Fatigue ^† 1	1/99 (1.01%)	2/100 (2.00%)
Fever ^† 1	0/99 (0.00%)	3/100 (3.00%)
Pain ^† 1	0/99 (0.00%)	1/100 (1.00%)
Immune system disorders
Allergic reaction ^† 1	1/99 (1.01%)	1/100 (1.00%)
Anaphylaxis ^† 1	1/99 (1.01%)	0/100 (0.00%)
Infections and infestations
Device related infection ^† 1	1/99 (1.01%)	0/100 (0.00%)
Kidney infection ^† 1	0/99 (0.00%)	1/100 (1.00%)
Lung infection ^† 1	1/99 (1.01%)	0/100 (0.00%)
Sepsis ^† 1	3/99 (3.03%)	4/100 (4.00%)
Skin infection ^† 1	1/99 (1.01%)	0/100 (0.00%)
Urinary tract infection ^† 1	7/99 (7.07%)	1/100 (1.00%)
Injury, poisoning and procedural complications
Fall ^† 1	1/99 (1.01%)	0/100 (0.00%)
Investigations
Blood bilirubin increased ^† 1	1/99 (1.01%)	0/100 (0.00%)
Metabolism and nutrition disorders
Dehydration ^† 1	2/99 (2.02%)	1/100 (1.00%)
Hypercalcemia ^† 1	1/99 (1.01%)	0/100 (0.00%)
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb ^† 1	1/99 (1.01%)	0/100 (0.00%)
Muscle weakness right-sided ^† 1	0/99 (0.00%)	1/100 (1.00%)
Nervous system disorders
Other nervous system disorders ^† 1	1/99 (1.01%)	0/100 (0.00%)
Peripheral motor neuropathy ^† 1	1/99 (1.01%)	0/100 (0.00%)
Psychiatric disorders
Confusion ^† 1	1/99 (1.01%)	0/100 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	0/99 (0.00%)	1/100 (1.00%)
Hematuria ^† 1	1/99 (1.01%)	2/100 (2.00%)
Other renal and urinary disorders ^† 1	0/99 (0.00%)	1/100 (1.00%)
Urinary tract obstruction ^† 1	2/99 (2.02%)	2/100 (2.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^† 1	0/99 (0.00%)	2/100 (2.00%)
Hypoxia ^† 1	1/99 (1.01%)	0/100 (0.00%)
Pleural effusion ^† 1	0/99 (0.00%)	1/100 (1.00%)
1 Term from vocabulary, The CTC version 4.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Arm 1	Arm 2
	Affected / at Risk (%)	Affected / at Risk (%)
Total	96/99 (96.97%)	97/100 (97.00%)
Blood and lymphatic system disorders
Febrile neutropenia ^† 1	7/99 (7.07%)	4/100 (4.00%)
Ear and labyrinth disorders
Hearing impaired ^† 1	3/99 (3.03%)	8/100 (8.00%)
Tinnitus ^† 1	5/99 (5.05%)	5/100 (5.00%)
Eye disorders
Blurred vision ^† 1	7/99 (7.07%)	4/100 (4.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	19/99 (19.19%)	29/100 (29.00%)
Constipation ^† 1	58/99 (58.59%)	55/100 (55.00%)
Diarrhea ^† 1	34/99 (34.34%)	27/100 (27.00%)
Dyspepsia ^† 1	10/99 (10.10%)	9/100 (9.00%)
Gastroesophageal reflux disease ^† 1	5/99 (5.05%)	8/100 (8.00%)
Mucositis oral ^† 1	14/99 (14.14%)	8/100 (8.00%)
Nausea ^† 1	46/99 (46.46%)	44/100 (44.00%)
Vomiting ^† 1	22/99 (22.22%)	19/100 (19.00%)
General disorders
Chills ^† 1	7/99 (7.07%)	2/100 (2.00%)
Edema limbs ^† 1	22/99 (22.22%)	22/100 (22.00%)
Fatigue ^† 1	71/99 (71.72%)	80/100 (80.00%)
Fever ^† 1	15/99 (15.15%)	13/100 (13.00%)
Flu like symptoms ^† 1	10/99 (10.10%)	3/100 (3.00%)
Non-cardiac chest pain ^† 1	3/99 (3.03%)	5/100 (5.00%)
Pain ^† 1	9/99 (9.09%)	12/100 (12.00%)
Infections and infestations
Upper respiratory infection ^† 1	4/99 (4.04%)	9/100 (9.00%)
Urinary tract infection ^† 1	21/99 (21.21%)	17/100 (17.00%)
Investigations
Weight loss ^† 1	14/99 (14.14%)	9/100 (9.00%)
Metabolism and nutrition disorders
Anorexia ^† 1	46/99 (46.46%)	44/100 (44.00%)
Dehydration ^† 1	9/99 (9.09%)	5/100 (5.00%)
Hypomagnesemia ^† 1	4/99 (4.04%)	6/100 (6.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	25/99 (25.25%)	26/100 (26.00%)
Back pain ^† 1	21/99 (21.21%)	34/100 (34.00%)
Bone pain ^† 1	11/99 (11.11%)	16/100 (16.00%)
Flank pain ^† 1	6/99 (6.06%)	8/100 (8.00%)
Generalized muscle weakness ^† 1	6/99 (6.06%)	9/100 (9.00%)
Muscle weakness lower limb ^† 1	12/99 (12.12%)	7/100 (7.00%)
Myalgia ^† 1	21/99 (21.21%)	22/100 (22.00%)
Neck pain ^† 1	0/99 (0.00%)	5/100 (5.00%)
Other musculoskeletal and connective tissue disorder ^† 1	0/99 (0.00%)	6/100 (6.00%)
Pain in extremity ^† 1	17/99 (17.17%)	29/100 (29.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain ^† 1	5/99 (5.05%)	5/100 (5.00%)
Nervous system disorders
Dizziness ^† 1	16/99 (16.16%)	6/100 (6.00%)
Dysgeusia ^† 1	15/99 (15.15%)	15/100 (15.00%)
Headache ^† 1	13/99 (13.13%)	13/100 (13.00%)
Paresthesia ^† 1	10/99 (10.10%)	3/100 (3.00%)
Peripheral motor neuropathy ^† 1	6/99 (6.06%)	6/100 (6.00%)
Peripheral sensory neuropathy ^† 1	72/99 (72.73%)	64/100 (64.00%)
Psychiatric disorders
Anxiety ^† 1	17/99 (17.17%)	17/100 (17.00%)
Depression ^† 1	7/99 (7.07%)	12/100 (12.00%)
Insomnia ^† 1	37/99 (37.37%)	24/100 (24.00%)
Renal and urinary disorders
Hematuria ^† 1	11/99 (11.11%)	11/100 (11.00%)
Other renal and urinary disorders ^† 1	1/99 (1.01%)	5/100 (5.00%)
Urinary frequency ^† 1	7/99 (7.07%)	6/100 (6.00%)
Urinary incontinence ^† 1	0/99 (0.00%)	5/100 (5.00%)
Urinary tract obstruction ^† 1	15/99 (15.15%)	11/100 (11.00%)
Urinary tract pain ^† 1	5/99 (5.05%)	1/100 (1.00%)
Reproductive system and breast disorders
Pelvic pain ^† 1	12/99 (12.12%)	13/100 (13.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	19/99 (19.19%)	27/100 (27.00%)
Dyspnea ^† 1	31/99 (31.31%)	32/100 (32.00%)
Pleural effusion ^† 1	2/99 (2.02%)	5/100 (5.00%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	62/99 (62.63%)	62/100 (62.00%)
Dry skin ^† 1	3/99 (3.03%)	6/100 (6.00%)
Other skin and subcutaneous tissue disorders ^† 1	5/99 (5.05%)	5/100 (5.00%)
Pruritus ^† 1	8/99 (8.08%)	5/100 (5.00%)
Rash acneiform ^† 1	5/99 (5.05%)	6/100 (6.00%)
Rash maculo-papular ^† 1	10/99 (10.10%)	14/100 (14.00%)
Vascular disorders
Hot flashes ^† 1	5/99 (5.05%)	6/100 (6.00%)
Hypertension ^† 1	6/99 (6.06%)	3/100 (3.00%)
Hypotension ^† 1	5/99 (5.05%)	1/100 (1.00%)
Thromboembolic event ^† 1	9/99 (9.09%)	10/100 (10.00%)
1 Term from vocabulary, The CTC version 4.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Wendy Parulekar
Organization:	Canadian Cancer Trials Group
Phone:	613-533-6430
EMail:	wparulekar@ctg.queenus.ca

Publications of Results:

Sridhar SS, Blais N, Tran B, Reaume MN, North SA, Stockler MR, Chi KN, Fleshner NE, Liu G, Robinson JW, Mukherjee SD, Rahim Y, Winquist E, Booth CM, Nguyen NT, Beardsley EK, Alimohamed NS, McDonald GT, Ding K, Parulekar WR. Efficacy and Safety of nab-Paclitaxel vs Paclitaxel on Survival in Patients With Platinum-Refractory Metastatic Urothelial Cancer: The Canadian Cancer Trials Group BL.12 Randomized Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):1751-1758. doi: 10.1001/jamaoncol.2020.3927.

Layout table for additonal information

Responsible Party:	Canadian Cancer Trials Group
ClinicalTrials.gov Identifier:	NCT02033993
Other Study ID Numbers:	BL12
First Submitted:	January 9, 2014
First Posted:	January 13, 2014
Results First Submitted:	February 21, 2019
Results First Posted:	January 18, 2020
Last Update Posted:	August 22, 2023

To Top