Clinical trial: NCT02033993
Section: Alternatives
Subsections: Note To Centre, Please Adjust This Section To Reflect Standard Or Usual Treatment In Accordance With Your Local Policy. Alternative Treatments

You do not have to take part in this study in order to receive treatment/care; other options may include, but are not limited to:  
- no therapy at this time - palliative care or Best Supportive Care (BSC). This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Best Supportive Care tries to keep you as active and comfortable as possible.  
- other experimental studies may be available if you do not take part in this study
Please talk to your study doctor or usual cancer doctor (if different from the study doctor) about the known benefits and risks of these other options before you decide to take part in this study. Your cancer doctor can also discuss with you what will happen if you decide not to undertake any treatment at this time.
Clinical trial: NCT02033993
Section: Confidentiality
Subsections: Confidentiality|How Will The Identity Of My Samples Be Protected?

Records identifying you at this centre will be kept confidential and, to the extent permitted by the applicable laws, will not be disclosed or made publicly available, except as described in this consent document.  
Qualified representatives of the following organizations may look at your original (identifiable) medical/clinical study records at the site where these records are held, for quality assurance (to check that the information collected for the study is correct and follows proper laws and guidelines).  
- NCIC Clinical Trials Group (NCIC CTG), the research group coordinating this study  
- The research ethics board who oversees the ethical conduct of this study in your hospital/clinic
- Celgene, the company which makes the drug nab-paclitaxel - Health Canada (because they oversee the use of drugs in Canada)
- Other regulatory authorities (because they oversee the use of new drugs in other countries)
Qualified representatives of the following organizations, in addition to those listed above, may receive information related to the study from your medical/clinical study records, containing your participant code, initials, sex, and date of birth, for quality assurance and data analysis.  
Note to centres: If there is planned disclosure of personal identifiers, or if they are used on any researchrelated information/documents, or if they are part of the unique identifier, this must be justified in the REB
application and approved. Please ensure that you are aware of your local REB's and your centre's policies with respect to the disclosure of personal identifiers; specifically date of birth and initials. If the REB or the centre mandates the disclosure only of partial date of birth (year/month), and/or of scrambled/coded initials, this will be accepted by NCIC CTG.  
Studies involving humans now routinely collect information on race and ethnicity as well as other characteristics of individuals because these characteristics may influence how people respond to different medications. Providing information on your race or ethnic origin is voluntary. Your name or other information that may identify you will not be used:  
- Australian Therapeutic Goods Administration (because they oversee the use of drugs in Australia)
- New Zealand Ministry of Health (because they oversee the use of drugs in New Zealand) - Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
- NHMRC Clinical Trials Centre
If the results of this study are published, your identity will remain confidential. It is expected that the information collected during this study will be used in analyses and will be published/ presented to the scientific community at meetings and in journals. This information may also be used as part of a submission to regulatory authorities around the world to support the approval of drugs used in this research. All of the organizations listed in the above confidentiality sections are required to have strict policies and procedures to keep the information they see or receive about you confidential, except where disclosure may be required by law. The study doctor will ensure that any personal health information collected for this study is kept in a secure and confidential location as required by law. There are federal and provincial laws that these organizations must comply with to protect your privacy. Even though the likelihood that someone may identify you from the study data is very small, it can never be completely eliminated. A copy of the consent form that you sign to enter the study may be included in your health record/hospital chart.  
Your family doctor will be informed that you are taking part in a study so that your study doctor and your family doctor can provide proper medical care. Any information sent outside of Canadian borders may increase the risk of disclosure of information because the laws in those countries dealing with protection of information may not be as strict as in Canada. However, all study data and/or samples, that is transferred outside of Canada will be coded (this means it will not contain your personal identifying information such as your name, address, medical health number or contact information). Any information will be transferred in compliance with all relevant Canadian privacy laws. By signing this consent form, you are consenting to the disclosure of your coded information to organizations located outside of Canada.

The identification that will be on your tissue samples kept in the bank may include your participant code, pathology identification number, initials and tumour bank code. The identification on blood samples may include your participant code and initials. Samples will be given only to researchers whose proposals have been approved by the NCIC Clinical Trials Group and who are bound by a confidentiality agreement. Any research done on your samples will have been approved by a research ethics board. A research ethics board oversees the ethical conduct of a study, including protection of patient rights, confidentiality and safety.  
Tissue used for research is identified only by a special code to protect your identity and privacy. Reports about any research done with your samples will not be given to you or your doctor. These reports will not be put in your medical records. The research using your samples will not affect your care.  
In the future, people who do research with your sample may need to know more about your health. While the researchers coordinating this study may give them reports about your health, they will not give them your name, address, phone number or any other information that will let them know who you are.
Clinical trial: NCT02033993
Section: Duration of Study Involvement
Subsections: Length Of Participation|Note To Centres: Centres Should Indicate The Overall Length Of Time Required Beyond That Of The Standard Or Usual Care At The Centre - Specifying The Difference In The Number Of Visits And The Length Of Time For Each Visit Plus The Time Needed To Complete Questionnaires Or Diaries.

Your treatment with nab-paclitaxel, if you are randomized to Group 1 (Experimental Arm), or paclitaxel, if you are randomized to Group 2 (Control Arm), will continue until your doctor feels you are no longer benefiting from your treatment.

No matter which group you are randomized to, and even if you stop treatment early, we would like to keep track of your health for the rest of your life to look at the long-term effects of your participation on this study.
Clinical trial: NCT02033993
Section: Participant Responsibilities
Subsections: Responsibilities

If you choose to participate in this study, you will be expected to:  
- Tell your study doctor about your current medical conditions; - Tell your study doctor about all prescription and non-prescription medications and supplements, including vitamins and herbals, and check with your study doctor before starting, stopping or changing any of these. This is for your safety as these may interact with the treatment you receive on this study. Tell your study doctor if you are thinking about participating on another research study;
- Return any questionnaires to the study doctor that you take home to complete; - Tell your study doctor if you become pregnant or father a child while participating on this study;
- Patients should not use St. John's Wort as an herbal medicine during study treatment.
Clinical trial: NCT02033993
Section: Participant's Rights
Subsections: Rights|What Are Your Rights As A Participant?

If you decide to stop participating in the study, your doctor will discuss other options with you and continue to treat you with the best means available. You will be told, in a timely manner, about new information that may be relevant to your willingness to stay in this study.  
You may withdraw your permission to use your personal health information for this study at any time by letting the study doctor know. However, this would also mean that you withdraw from the study. Your study data that was recorded before you withdrew will be used but no information will be collected or sent to the sponsor after you withdraw your permission. Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected.  
By signing this form you do not give up any of your legal rights against the investigators, sponsor or involved institutions for compensation, nor does this form relieve the investigators, sponsor or involved institutions of their legal and professional responsibilities. You will be given a copy of this signed and dated consent form prior to participating in this study.

Taking part in the tissue/ blood collection and banking part of this study is voluntary. You may choose not to take part, or may at any time withdraw your consent for this portion of the study and ask that the collected tissue / blood samples not be used. Deciding not to take part, or deciding to withdraw your consent for this portion of the study later, will not result in any penalty or loss of benefits to which you are entitled. If you decide to stop participating, and no longer want your tissue and/or blood samples to be used in this research, you should tell your doctor. Your doctor will notify the NCIC Clinical Trials Group (NCIC CTG) who will ensure the samples are destroyed (blood) or returned to the hospital where you had your original biopsy or surgery
(tissue). If tests have already been done on your sample and included in an analysis or publication, it will not be possible to withdraw these. All the information provided in the main study consent form about confidentiality, costs, your rights as a participant, and who to contact with questions, applies to this consent form as well.
Clinical trial: NCT02033993
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Of Participation|Rarely (1 - 4%):|Reproductive Risks

Participating on this study will put you at risk for the side effects listed below. You should discuss these with your doctor. As with any experimental drug additional unexpected and sometimes serious side effects are a possibility.  
Your doctor will watch you closely to see if you have side effects. When possible, other drugs will be given to you to make side effects less serious and more tolerable. Many side effects go away shortly after chemotherapy is stopped but in some cases side effects can be serious, longlasting, permanent, or may even cause death.  
Risks and side effects related to the experimental drug NAB-PACLITAXEL we are studying include:  
Very likely (21% or more):
- nausea and vomiting (If needed, nausea medication will be prescribed before and during treatment.)
- lowering of blood cell counts (red cells, white cells and platelets) which could increase your risk of developing anemia, infection or bleeding/ bruising
- diarrhea
- constipation - anorexia
- dehydration
- hair loss - fatigue and/or tiredness
- general weakness, loss of strength
- joint and/or muscle pain - infection including pneumonia, blood infection (sepsis), shingles, urinary tract infection, upper respiratory infection, sore throat, cold sores, sinusitis, yeast infection of the mouth (thrush). Rarely infections may be serious and or life threatening
Admin Update \#1: 2014-JAN-10; AMEND \#2: 2014-DEC-19
- abnormal heart rhythm seen in electrocardiogram (ECG) which could rarely be a sign of a more severe heart problem
- numbness, tingling in hands and feet, possibly with strength reduced (may be severe)
- abnormal liver function as seen by blood tests (in rare cases this can be life threatening)
Less likely (5 - *20%):*
- fever
- shortness of breath - cough
- rash or itchiness
- swelling of legs, arms, hands or feet due to accumulation of fluid
- inflammation or sores in the mouth and lining of the intestine which could become severe
- low blood pressure (hypotension)
- changes in vision including blurred vision and less likely, inflammation of the cornea or fluid accumulation leading to decreased vision. These are generally reversible but rarely can lead to permanent loss of vision.

- pain (itching, swelling, redness) at the injection and/or catheter sites
- nail changes (changes in colour of nail bed) - allergic reactions (swelling of the face, lips or tongue, difficulty breathing, rash, flushing or fainting) (very rarely can be life threatening).  
- abnormal heart beat (faster, slower, or irregular), chest pain or heart attack or heart failure.  
- high blood pressure (hypertension)
- abnormal kidney function seen by blood tests - inflammation of the colon
- blockage of the intestine, formation of a hole in the lining of the intestine
- inflammation of the pancreas - severe life threatening damage to the lungs which can lead to inflammation and fluid in the lungs and scarring of lung tissue
- poor functioning of your brain due to changes in the salts in your blood.  
- stroke - confusion, dizziness/light-headedness
- depression, mood changes
- weakness or loss of function of a muscle caused by damage to a nerve - serious skin disorders such as Stevens-Johnson syndrome, a condition that affects your skin and mucous membranes which begins with flu-like symptoms followed by a painful red or purplish rash that spreads and blisters and may be followed by shedding of the top layer of skin Risks and side effects related to the experimental drug PACLITAXEL we are studying include:
Very likely (21% or more):
- nausea and vomiting (If needed, nausea medication will be prescribed before and during treatment.)
- diarrhea Admin Update \#1: 2014-JAN-10; AMEND \#2: 2014-DEC-19
- lowering of blood cell counts (red cells, white cells and platelets) which could increase your risk of developing anemia, infection or bleeding/ bruising
- inflammation or sores in the mouth and lining of the intestine which could become severe
- allergic reactions (swelling of the face, lips or tongue, difficulty breathing, shortness of breath, a fast heart rate, changes in blood pressure, excessive sweating, chills, pain, rash, flushing or fainting).  
- numbness, tingling in hands and feet, possibly with strength reduced (may be severe)
- fatigue and/or tiredness
- general weakness, loss of strength
- joint and/or muscle pain
- infection including pneumonia, blood infection (sepsis), shingles, urinary tract infection, upper respiratory infection, sore throat, cold sores, sinusitis, yeast infection of the mouth (thrush). Rarely infections may be serious and/or life threatening.  
- abnormal heart rhythm seen in electrocardiogram (ECG) which could rarely be a sign of a more severe heart problem
- abnormal liver function as seen by blood tests (in rare cases this can be life threatening) - hair loss Less likely (5 - *20%):*
- low blood pressure (hypotension) - fever
- constipation
- abnormal kidney function seen by blood tests - pain (itching, swelling, redness) at the injection and/or catheter sites
- swelling of legs, arms, hands or feet due to accumulation of fluid
- changes in vision including blurred vision and less likely, inflammation of the cornea or fluid accumulation leading to decreased vision. These are generally reversible but rarely can lead to permanent loss of vision.  
- abnormal heart beat (faster, slower, or irregular), chest pain or heart attack or heart failure. - fainting
- high blood pressure (hypertension)
- nail changes (changes in colour of nail bed)
- inflammation of the colon
- blockage of the intestine, formation of a hole in the lining of the intestine
- inflammation of the pancreas - severe life threatening damage to the lungs which can lead to inflammation and fluid in the lungs and scarring of lung tissue
- hearing loss
- weakness or loss of function of a muscle caused by damage to a nerve - abnormal brain function, seizures
- dehydration
- serious skin disorders such as Stevens-Johnson syndrome, a condition that affects your skin and mucous membranes which begins with flu-like symptoms followed by a painful red or purplish rash that spreads and blisters and may be followed by shedding of the top layer of skin It is possible that other drugs (prescription and non-prescription drugs), vitamins, or herbals can interact with the drugs used in this study. This can result in either the drugs not working as expected or result in severe side effects.  
Long term effects of the chemotherapy used in this study include an increased risk of developing other cancers.  
Some cancer treatments such as chemotherapy (including nab-paclitaxel and paclitaxel) or other drugs increase the risk of blood clots in your veins. Please tell your doctor if you have any new swelling in a leg or arm or have a sudden problem with your breathing. These may be signs of a clot forming or a clot moving to your lungs. Rarely, blood clots can be fatal.  
A Data Safety Monitoring Board, an independent group of experts, will be reviewing the data from this research throughout the study.

Nab-paclitaxel and paclitaxel may harm an unborn baby (fetus). You must not become pregnant or father a baby while taking nab-paclitaxel and paclitaxel and for 30 days after the last dose. Your study doctor will discuss methods with you to ensure that you do not become pregnant or father a baby during the study.  
Women should not nurse (breastfeed) a baby while taking study treatment and for 30 days after the last dose because the drugs used in this study might be present in breast milk and could be harmful to a baby.  
If you become pregnant or father a child during this study or for 30 days after you stop taking the study drug, then you should immediately notify your study doctor. Your study doctor will let the sponsor know about the pregnancy.  
If you become pregnant, the researchers or sponsors for this study will access information on the outcome of the pregnancy (the child's health etc.). This information will be gathered from your medical/study record. This may also involve contacting you to ask about the health of your child. We may also ask to contact the child's father to get information related to the pregnancy. If you become pregnant and do not want the researchers/sponsors to collect this information, you must let your study doctor know.  
If you father a child, the researchers or sponsor for this study will ask to contact the child's mother to collect information on the outcome of the pregnancy (the child's health, etc.). Your partner will be given a separate consent document to sign to give permission for the collection of this information, if a pregnancy should happen.  
Some of the drugs used in this study may make you unable to have children in the future. Your study doctor will discuss this with you.
Clinical trial: NCT02033993
Section: Procedures
Subsections: Assignment To A Group|For Group 1 (Experimental Arm): Nab-Paclitaxel|Group 2 (Control Arm): Paclitaxel|Non-Experimental Procedures (Screening Procedures)|- Bone Scan|Questionnaires|Optional Sample Collection And Banking

If you decide to participate then you will be "randomized" into one of the groups described below. Randomization means that you are put into a group by chance (like flipping a coin).  
There is no way to predict which group you will be assigned to. You will have an equal chance of being placed in either group. Neither you nor your doctor can choose what group you will be in. You will be told which treatment you are to get.

If you are randomized to Group 1 you will be given the experimental drug nab-paclitaxel. Nabpaclitaxel will be given into one of your veins by needle every 21 days. The procedure will take about 1 hour. You will continue on drug indefinitely as long as you are responding and able to tolerate the drug well. The dose may be changed if you have side effects.

If you are randomized to Group 2 you will be given the experimental drug paclitaxel. Paclitaxel will be given into one of your veins by needle every 21 days. The procedure will take about 4 hours. You will continue on drug indefinitely as long as you are responding and able to tolerate the drug well. The dose may be changed if you have side effects.  
No matter which Group you are randomized to, antiemetics, drugs that are effective against vomiting and nausea, and other medications, such as steroids, may be given before you receive your treatment to try to prevent some of the possible side effects from treatment.

The following tests will be done at the hospital or clinic to make sure that you are eligible for this study: Some of these tests may have been done as part of your standard care, in which case the results of those tests may be used.  
- blood tests  
- physical examination
- pregnancy test - chest x-ray - magnetic resonance imaging (MRI) - a scan that uses a strong magnet to produce pictures of areas inside the body such as organs and other tissue, and inside of bones.  
- computed tomography (CT) scan- a series of x-rays of the body from many angles that are turned into 3-dimensional pictures on a screen. CT scans often involve injecting a dye into your vein.

Many of these tests will also be repeated during the study. Some of these tests may be done more frequently than if you were not taking part in this study.

You will be provided with questionnaires before starting this study, on days 5 to 7 of cycles 1 and 2 (one cycle equals every 21 days), day 1 of cycle 4 and then on day 1 of every 4 cycles while you are receiving study treatment. If you come off study treatment, then you will be given the questionnaire at every 6 week clinic visit until your cancer gets worse and/or your doctor decides to give you another treatment. The purposes of these questionnaires are to understand how your treatment and illness affects your quality of life. These questionnaires will each take about 10 minutes to complete. In addition, you will be asked to complete a health and demographic questionnaire around the time you start treatment. This questionnaire takes around 20 minutes to complete. The purpose of this questionnaire is to help researchers understand how different factors (such as your family history, and information about your life), may relate to bladder cancer. This includes trying to understand which factors might influence the likelihood of getting bladder cancer, predict who can benefit most from or how people respond to treatment, and effect quality of life. This information may also be used to help understand how the trial results relate to the general population. These questionnaires ask for information on where you were born, your medical history, your family's medical history, information on your exposure to cigarettes and alcohol use, physical activity, past and present occupations, educational history, and marital status. This questionnaire also collects information on race and ethnicity as well as other characteristics of individuals because these characteristics may influence how people respond to different medications.The identification on the questionnaire will include your participant code, which includes your initials. The questionnaires will be sent to NCIC Clinical Trials Group. The information you provide is for research purposes only and will remain strictly confidential.  
Some of the questions are personal; you can choose not to answer these if you wish. The individuals (e.g. doctors, nurses, etc.) who are not involved in the study will not review your responses to these questions—if you wish them to know this information please bring it to their attention.

The researchers doing this study are interested in doing additional research now or in the future on the samples collected from you. You will be given an additional optional study consent form to read and sign if you wish to give permission for the samples to be banked (stored) for future research purposes. You may decide not to participate in the "optional" study and still participate in this main study.
Clinical trial: NCT02033993
Section: Purpose of Research
Subsections: Purpose

The purpose of this study is to compare the effects on you and your urothelial cancer of nabpaclitaxel 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 trial: NCT02033993
Section: Withdrawal from Study
Subsections: Early End To Participation

The researchers can take you off the study treatment early for reasons such as:  
- The treatment does not work for you and your cancer gets worse.  
- You are unable to tolerate the study treatment. - New information shows that the study treatment is no longer in your best interest.  
- Your doctor no longer feels this is the best treatment for you.  
- The NCIC CTG decides to stop the study. - If you become pregnant.