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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 Survival

Clinical 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

Page last updated: August 23, 2015

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