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

NCT02033993 | Completed Phase 2 Results DMC

• 1 other identifier: BL12
• Study Type: interventional
• Target: 199
• Locations: 2 countries
• Sites: 37

Brief Summary

The purpose of this study is to compare the effects on urothelial cancer of nab-paclitaxel compared to paclitaxel to treat this disease. This research is being done because currently there is no effective treatment for urothelial cancer that has progressed after prior chemotherapy.

Conditions

Urothelial Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  PFS is defined as the time from randomization to the first observation of disease progression or death due to any cause.

  42 months

Secondary Outcomes (4)

• Overall Survival

  42 months

• Clinical Benefit Rate

  42 months

• Time to Response

  42 months

• Health Related Quality of Life Evaluated Using EORTC-C15-Pal

  42 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Nab-Paclitaxel - 260mg/m2: q21 days

Drug: Nab-Paclitaxel

Arm 2

ACTIVE COMPARATOR

Paclitaxel - 175mg/m2: q21 days

Drug: Paclitaxel

Interventions

Nab-Paclitaxel DRUG

Arm 1

Paclitaxel DRUG

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of TCC of the urinary tract (bladder, urethra, ureter, renal pelvis) and metastatic or locally advanced inoperable disease extent (T4, N2, N3 or M1 disease)
• Note: Mixed histologies (except small cell) permitted if predominately TCC by IHC.
• Patients must have evidence of metastatic disease, but measurable disease is not mandatory. To be considered evaluable for the overall response rate (complete and partial response), patients must have at least one measurable lesion as follows:
• X-ray, physical exam ≥ 20 mm
• Conventional CT scan, MRI ≥ 20 mm
• Spiral CT scan ≥ 10 mm
• Male or female, 18 years of age or older.
• ECOG performance status ≤ 2 at study entry
• Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to randomization. If anemic, patients should be asymptomatic and should not be decompensated.
• Absolute neutrophil count (ANC) ≥ 1.5 x10\^9/L (1,500 cells/mm3)
• Platelet count ≥ 90 x10\^9/L (100,000/mm3)
• Hemoglobin ≥ 90 g/L
• Calculated creatinine clearance \> 25 mL/min (Cockcroft and Gault formula)
• Total bilirubin ≤ 1.5 times the upper limit of normal (≤ 2.5X if Gilbert's disease)
• ALT (SGPT) ≤ 3 x ULN or ≤ 5 x ULN if hepatic metastases are present

You may not qualify if:

• A candidate for potentially curative surgery or radiotherapy.
• Patients with brain metastases are ineligible if they meet at least one of the following criteria:
• diagnosis within 3 months from randomization
• untreated brain metastases
• unstable brain metastasis as defined by:
• cavitation or hemorrhage in the brain lesion
• symptomatic state
• daily prednisone or equivalent use greater than 10 mg
• Patients do not need CT/MRI scans to rule out brain metastases unless there is a clinical suspicion of CNS metastases.
• Patients with serious illness or medical condition which would not permit the patient to be managed according to the protocol including, but not limited to:
• any evidence of severe or uncontrolled systemic disease (i.e. known cases of hepatitis B or C or human immunodeficiency virus (HIV)).
• patients with active or uncontrolled infections.
• Screening for chronic conditions is not required, although patients known to have such conditions at screening should not be included.
• Women who are pregnant or breastfeeding.
• Patients with history of allergic or hypersensitivity reactions to any study drug or their excipients or with a history of allergic reactions attributed to compounds with similar chemical composition to any of the study drugs.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Australian and New Zealand Urogenital and Prostate Cancer Trials Group: collaborator
• Celgene: collaborator

Study Sites (37)

Townsville Hospital

Douglas, Queensland, 4814, Australia

Location

Nambour General Hospital

Nambour, Queensland, 4560, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Ashford Cancer Care Research

Kurralta Park, South Australia, 5037, Australia

Location

Prince of Wales Hospital

Sydney, South Australia, 2031, Australia

Location

Concord Cancer Centre

Sydney, South Australia, 2139, Australia

Location

Liverpool Hospital

Sydney, South Australia, 2170, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

St Vincents Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Peninsula Oncology Centre

Frankston, Victoria, 3199, Australia

Location

University Hospital Geelong

Geelong, Victoria, 3320, Australia

Location

Epworth Healthcare Freemasons Hospital

Richmond, Victoria, 3121, Australia

Location

Western Hospital (renamed to Footscray Hospital)

St Albans, Victoria, 3021, Australia

Location

Border Medical Oncology (Murray Valley Private Hospital)

Wodonga, Victoria, 3690, Australia

Location

Royal Perth Hospital (renamed to Fiona Stanley Hospital)

Perth, Western Australia, 6150, Australia

Location

Port Macquarie Base Hospital

Port Macquarie, 2444, Australia

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, L3Y 2P9, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

The Research Institute of the McGill University

Montreal, Quebec, H4A 3J1, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Centre hospitalier regional de Trois-Rivieres

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

• 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.

  PMID: 32940628 RESULT

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Wendy Parulekar
• Organization: Canadian Cancer Trials Group

wparulekar@ctg.queenus.ca

613-533-6430

Study Officials

• Srikala Sridhar

  Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario Canada

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 13, 2014
• Study Start: March 11, 2014
• Primary Completion: May 3, 2018
• Study Completion: October 28, 2020
• Last Updated: August 22, 2023
• Results First Posted: January 18, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (18); CA (19)