Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen.
Information source: NCIC Clinical Trials Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urothelial Cancer
Intervention: Nab-Paclitaxel (Drug); Paclitaxel (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: NCIC Clinical Trials Group Official(s) and/or principal investigator(s): Srikala Sridhar, Study Chair, Affiliation: Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario Canada
Overall contact: Wendy Parulekar, Phone: 613-544-2630, Email: wparulekar@ctg.queensu.ca
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression-Free Survival
Secondary outcome: Overall SurvivalClinical Benefit Rate Time to Response and Response Duration Nature, severity and frequency of toxicities Quality of Life Cost and cost utility ratios between the two arms
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
- 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 NCIC CTG policy, protocol treatment is to begin within 5 working
days of patient randomization.
Exclusion Criteria:
- A candidate for potentially curative surgery or radiotherapy.
- Patients with brain metastases are ineligible if they meet at least one of the
following criteria:
1. diagnosis within 3 months from randomization
2. untreated brain metastases
3. 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:
1. . any evidence of severe or uncontrolled systemic disease (i. e. known cases of
hepatitis B or C or human immunodeficiency virus (HIV)).
2. 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.
Locations and Contacts
Wendy Parulekar, Phone: 613-544-2630, Email: wparulekar@ctg.queensu.ca
Port Macquarie Base Hospital, Port Macquarie 2444, Australia; Recruiting Stephen Begbie
Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada; Recruiting Joseph Dean Ruether, Phone: 403 521-3093
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada; Recruiting Naveen S. Basappa, Phone: 780 432-8762
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia V5Z 4E6, Canada; Recruiting Bernhard Eigl, Phone: 604 877-6000, Ext: 2707
QEII Health Sciences Centre, Halifax, Nova Scotia B3H 1V7, Canada; Recruiting Robyn J. Macfarlane, Phone: 902 473-6106
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario L8V 5C2, Canada; Recruiting Som Mukherjee, Phone: 905 387-9495, Ext: 64605
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario K7L 5P9, Canada; Recruiting Chris Booth, Phone: 613 549-6666, Ext: 4505
London Regional Cancer Program, London, Ontario N6A 4L6, Canada; Recruiting Eric W. Winquist, Phone: 519 685-8261
Stronach Regional Health Centre at Southlake, Newmarket, Ontario L3Y 2P9, Canada; Recruiting Yasmin H. Rahim, Phone: 905 895-4521, Ext: 6596
Lakeridge Health Oshawa, Oshawa, Ontario L1G 2B9, Canada; Recruiting Gregory Lo, Phone: 905 576-8711, Ext: 3625
Ottawa Hospital Research Institute, Ottawa, Ontario K1H 8L6, Canada; Recruiting M. Neil Reaume, Phone: 613 737-7700, Ext: 70172
Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada; Recruiting Srikala Sridhar, Phone: 416 946-4501, Ext: 2520
Hopital Charles LeMoyne, Greenfield Park, Quebec J4V 2H1, Canada; Recruiting Trung Nghia Nguyen, Phone: 450 466-5000, Ext: 2318
CHUM - Hopital Notre-Dame, Montreal, Quebec H2L 4M1, Canada; Recruiting Normand Blais, Phone: 514 890-8444
McGill University - Dept. Oncology, Montreal, Quebec H2W 1S6, Canada; Recruiting Marie VanHuyse, Phone: 514 934-1934
Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec J1H 5N4, Canada; Recruiting Jean-Francois Castilloux, Phone: 819 346-1110
Townsville Hospital, Douglas, Queensland 4814, Australia; Not yet recruiting Abhishek Joshi
ICON Cancer Care, Milton, Queensland 4064, Australia; Not yet recruiting Paul Vassey
Sunshine Coast Cancer Service, Nambour, Queensland 4560, Australia; Not yet recruiting Michelle Cronk
Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada; Recruiting Vamsee Torri, Phone: 306 766-2691
Saskatoon Cancer Centre, Saskatoon, Saskatchewan S7N 4H4, Canada; Recruiting Nayyer Iqbal, Phone: 306 655-2710
Flinders Medical Centre, Bedford Park, South Australia 5042, Australia; Recruiting Ganessan Kichenadasse, Phone: 88 204-4830
Ashford Cancer Care Research, Kurralta Park, South Australia 5037, Australia; Recruiting Christopher Hocking
Concord Cancer Centre, Sydney, South Australia 2139, Australia; Recruiting Martin Stockler, Phone: 2 9515-5494
Liverpool Hospital, Sydney, South Australia 2170, Australia; Not yet recruiting Bavanthi Balakrishnar
Prince of Wales Hospital, Sydney, South Australia 2031, Australia; Recruiting Elizabeth J. Hovey, Phone: 2 9828-5283
Royal Hobart Hospital, Hobart, Tasmania 7000, Australia; Not yet recruiting Louise M. Nott, Phone: 36 222-8120
Box Hill Hospital, Box Hill, Victoria 3128, Australia; Recruiting Carmel Pezaro
St Vincents Hospital Melbourne, Fitzroy, Victoria 3065, Australia; Recruiting Anthony Dowling, Phone: 3 9288-3155
Frankston Hospital, Frankston, Victoria 3199, Australia; Recruiting Emma Beardsley, Phone: 604 877-6000, Ext: 2017
Peninsula Oncology Centre, Frankston, Victoria 3199, Australia; Not yet recruiting Vinod Ganju, Phone: 3 9784-7290
University Hospital Geelong, Geelong, Victoria 3320, Australia; Not yet recruiting David X Campbell
Epworth Healthcare Freemasons Hospital, Richmond, Victoria 3121, Australia; Recruiting Ben Tran, Phone: 39 342-7560
Western Hospital (renamed to Footscray Hospital), St Albans, Victoria 3021, Australia; Not yet recruiting David X Campbell
Border Medical Oncology (Murray Valley Private Hospital), Wodonga, Victoria 3690, Australia; Not yet recruiting Craig Underhill, Phone: 2 6051-5300
Royal Perth Hospital (renamed to Fiona Stanley Hospital), Perth, Western Australia 6150, Australia; Not yet recruiting Thomas Ferguson
Additional Information
Starting date: February 2014
Last updated: August 10, 2015
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