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Urothelial CancerPhase 2NCT02033993

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

A Phase 2 study testing Nab-Paclitaxel and Paclitaxel in people with Urothelial Cancer, run by Canadian Cancer Trials Group at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Cancer
What is being tested?
Nab-Paclitaxel and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
37 sitesin 2 countries
Study dates
11 Mar 2014to 28 Oct 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 27Show fewer
  • 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
  • Patients may have had prior neoadjuvant or adjuvant therapy for completely resected disease, provided it was completed at least 12 months prior to randomization. Patients must have recovered from any acute toxic effects to ≤ Grade 2 from any prior treatments. Neoadjuvant or adjuvant chemotherapy will be considered to have been first line therapy in the metastatic setting if the patient progressed within 12 months of the last dose.
  • Patients must have received one and only one prior chemotherapeutic regimen which included a platinum (at least one cycle) for metastatic/recurrent disease. Treatment must have been discontinued at least 4 weeks prior to randomization in this study. Patients must have recovered from any acute toxic effects to ≤ Grade 2 from any prior treatments
  • Patients may not have had any prior therapy with a taxane in any setting.
  • Patients may have had prior investigational agents but these must have been discontinued at least 4 weeks prior to randomization. Patients must have recovered from any acute toxic effects to ≤ Grade 2 from any prior treatments.
  • Prior treatments with radiation therapy in the adjuvant and/or metastatic setting are permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy and all treatment related adverse events are ≤ Grade 1 at the time of randomization.
  • Patients may have had prior surgery provided that at least 4 weeks elapsed between the end of surgery and randomization onto the study. Patients must have recovered from any acute toxic effects to ≤ Grade 2 from any prior treatments.
  • Patients may have peripheral neuropathy from previous treatments providing that it is ≤ Grade 1.
  • Patient is able (i.e. sufficiently fluent) and willing to complete the health and demographic, quality of life, and health utilities questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization. Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to randomization. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, bilateral tubal ligation or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.
  • Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up.
  • In accordance with CCTG policy, protocol treatment is to begin within 5 working days of patient randomization.

Who cannot join

  • 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
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  • 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.
  • Planned concomitant participation in another clinical trial of an experimental agent, vaccine or device. Concomitant participation in observational studies is acceptable.
  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Prior prostate cancer is allowed provided that it is an incidental finding at cystoprostatectomy with a PSA <0.5 ng/mL at randomization or a prior diagnosis of low risk prostate cancer at any time as defined by ≤T2, a Gleason Score of 6 or less and PSA <10 ng/mL.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

Canada19 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • Centre hospitalier regional de Trois-Rivieres

    Trois-Rivières, Quebec, G8Z 3R9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Australia18 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Townsville Hospital

    Douglas, Queensland, 4814

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Peninsula Oncology Centre

    Frankston, Victoria, 3199

  • University Hospital Geelong

    Geelong, Victoria, 3320

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Ashford Cancer Care Research

    Kurralta Park, South Australia, 5037

  • Nambour General Hospital

    Nambour, Queensland, 4560

  • Royal Perth Hospital (renamed to Fiona Stanley Hospital)

    Perth, Western Australia, 6150

  • Port Macquarie Base Hospital

    Port Macquarie, 2444

  • Epworth Healthcare Freemasons Hospital

    Richmond, Victoria, 3121

  • Western Hospital (renamed to Footscray Hospital)

    St Albans, Victoria, 3021

  • Prince of Wales Hospital

    Sydney, South Australia, 2031

  • Concord Cancer Centre

    Sydney, South Australia, 2139

  • Liverpool Hospital

    Sydney, South Australia, 2170

  • Border Medical Oncology (Murray Valley Private Hospital)

    Wodonga, Victoria, 3690

Other trials in Australia

About this study

Official title: A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advanced Urothelial Cancer Progressing on or After a Platinum Containing Regimen.

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.

Read the detailed description

Nab-paclitaxel is a formulation of the chemotherapeutic drug paclitaxel that is combined with a human protein called albumin. In Canada, nab-paclitaxel is currently approved for the treatment of metastatic breast cancer. This drug has been tested in other cancers and has shown promising activity in lung cancer, melanoma and pancreatic cancer. Information from research studies suggests that nab-paclitaxel may be a useful treatment for urothelial cancer.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02033993
Study groupRoleWhat they receive
Arm 1Active comparatorNab-Paclitaxel - 260mg/m2: q21 days
Receives: Drug: Nab-Paclitaxel
Arm 2Active comparatorPaclitaxel - 175mg/m2: q21 days
Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 42 months

Secondary outcomes (4)

  1. Overall Survival

    Time from randomization to the date of death due to any causes, or censored at last contact date.

    Measured: 42 months

  2. Clinical Benefit Rate

    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.

    Measured: 42 months

  3. Time to Response

    Time from the date of randomkization to the date of objective response according to RECIST Response Criteria was first achieved.

    Measured: 42 months

  4. Health Related Quality of Life Evaluated Using EORTC-C15-Pal

    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.

    Measured: 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2014 (estimated)
  2. Study start11 Mar 2014
  3. Primary completion3 May 2018
  4. Study completion28 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02033993
Sponsor's protocol ID
BL12
Status last verified
Oct 2020
First submitted
9 Jan 2014
Last updated
22 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32940628

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-Paclitaxel and Paclitaxel in people with Urothelial Cancer, run by Canadian Cancer Trials Group at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: 42 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02033993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.

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