appendix b potential drug interactions
what happens if i am

It is important that you tell your study doctor, __________________ *[investigator's name(s)],* if you feel that you have been injured because of taking part in this study. You can tell the doctor in person or call him/her at __________________ *[telephone number].* You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment.
appendix b potential drug interactions
will my medical information be

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. Organizations that may look at and/or copy your medical records, including research records, for research, quality assurance, and data analysis include:
- The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people.  
- Qualified representatives from the pharmaceutical collaborator may also review the medical records.  
- Designated investigators from other cancer centers participating in this study, including the University of Southern California/Norris Comprehensive Cancer Center; the University of California, Davis, Cancer Center; and Stanford University Medical Center A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. [Note to Local Investigators: The NCI has recommended that HIPAA regulations be addressed by the local institution. The regulations may or may not be included in the informed consent form depending on local institutional policy.]
appendix b potential drug interactions
what are my rights if

Taking part in this study is your choice. You may choose either to take part or not to take part in this study. If you decide to participate, you may leave the study at any time. No matter what decision you make, there will be no penalty to you, and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our center. We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form. Who can answer my questions about the study? You can talk to your study doctor about any questions or concerns you have about this study. Contact your study doctor __________________ *[name(s)]* at __________________ [telephone number].  
For questions about your rights while taking part in this study, call the
________________________ *[name of center]* Institutional Review Board (a group of people who review the research to protect your rights) at __________________ (telephone *number).* [Note to Local Investigator: Contact information for patient representatives or other *individuals* in a local institution who are not on the IRB or research team but take calls *regarding clinical* trial questions can be listed here.]
appendix b potential drug interactions
where can i get more

You may call the National Cancer Institute's Cancer Information Service at: 1-800-4-CANCER
(1-800-422-6237). You may also visit the NCI Web site at http://cancer.gov/
- For NCI's clinical trials information, go to: http://cancer.gov/clinicaltrials/ - For NCI's general information about cancer, go to http://cancer.gov/cancerinfo/
You will get a copy of this form. If you want more information about this study, ask your study doctor.
appendix b potential drug interactions
use of specimens and data

To advance science, it is helpful for researchers to share information they get from studying human samples. They do this by putting it into one or more scientific databases, where it is stored along with information from other studies. A researcher who wants to study the information must apply to the database and be approved. Researchers use specimens and data stored in scientific databases to advance science and learn about health and disease. We plan to keep some of your specimens and data that we collect and use them for future research and share them with other researchers. We will not contact you to ask about each of these future uses. These specimens and data will be stripped of identifiers such as name, address or account number, so that they may be used for future research on any topic and shared broadly for research purposes. Your specimens and data will be used for research purposes only and will not benefit you. It is also possible that the stored specimens and data may never be used. Results of research done on your specimens and data will not be available to you or your doctor. It might help people who have cancer and other diseases in the future.  
My specimens and data may be kept for use in research to learn about, prevent, or treat cancer or other health problems. Yes No Initials_________
appendix b potential drug interactions
signature

I have been given a copy of all _____ *[insert total of number of pages]* pages of this form. I have read it or it has been read to me. I understand the information and have had my questions answered. I agree to take part in this study.
appendix b potential drug interactions
participant date

APPENDIX H: PD Collection Worksheets  
| Date:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | PD SAMPLE COLLECTION SHEET: Cycle 1 Day 1   |                                                   |                 |        |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------|-----------------|--------|
| Protocol: 9284                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | Ht:                                         | Page ______________for  Sample Pick-up Lab phone: | Research Nurse: |        |
| Dose level:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | XL184 Dose:                                 | Wt:                                               | Phone:          | Pager: |
| PI:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |                                             |                                                   |                 |        |
| Patient ID:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | BSA:                                        | Phone:                                            |                 |        |
| Diagnosis/subtype: PLEASE LABEL EACH TUBE WITH ACTUAL DATE AND TIME OF SAMPLE COLLECTION Day Time Instructions Ideal  Actual  Record comments (i.e., if collection missed), and  Time Time sign each time you collect a sample Day 1 Prior to drug PD 300 K2 EDTA 3 mL x1 Label tube: sample number, date and time ----- Day 1 Prior to drug PD 400 6 mL NaHep x1 Label tube: sample number, date and time ------ Administer XL184, Time: Day 1 3-6 hours post  PD 301 K2 EDTA 3 mL x1 dose Label tube: sample number, date and time PD 401 6 mL NaHep x1 Day 1 4 hours post  dose Label tube: sample number, date and time |                                             |                                                   |                 |        |  
Date: PD SAMPLE COLLECTION SHEET: Cycle 2 Day 1  
| Protocol: 9284   | Ht:         | Page ______________for  Sample Pick-up Lab phone:   | Research Nurse:   |        |
|------------------|-------------|-----------------------------------------------------|-------------------|--------|
| Dose level:      | XL184 Dose: | Wt:                                                 | Phone:            | Pager: |
| PI:              |             |                                                     |                   |        |
| Patient ID:      | BSA:        | Phone:                                              |                   |        |  
Diagnosis/subtype:  
| PLEASE LABEL EACH TUBE WITH ACTUAL DATE AND TIME OF SAMPLE COLLECTION   |                                          |                                                               |        |        |                                                   |
|-------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------|--------|--------|---------------------------------------------------|
| Day                                                                     | Time                                     | Instructions                                                  | Ideal  | Actual | Record comments (i.e., if collection missed), and |
| Time                                                                    | Time                                     | sign each time you collect a sample                           |        |        |                                                   |
| Day 1                                                                   | Prior to drug                            | PD 402 6 mL NaHep x1 Label tube: sample number, date and time | ------ |        |                                                   |
| Administer XL184, Time:                                                 |                                          |                                                               |        |        |                                                   |
| Day 1                                                                   | 3-6 hours post                           | PD 302 K2 EDTA 3 mL x1                                        |        |        |                                                   |
| dose                                                                    | Label tube: sample number, date and time |                                                               |        |        |                                                   |  
| Date:              | PD SAMPLE COLLECTION SHEET: Day 1 each cycle/determined by PI   |                                                   |                 |        |
|--------------------|-----------------------------------------------------------------|---------------------------------------------------|-----------------|--------|
| Protocol: P9284    | Ht:                                                             | Page ______________for  Sample Pick-up Lab phone: | Research Nurse: |        |
| Dose level:        | XL184 Dose:                                                     | Wt:                                               | Phone:          | Pager: |
| PI:                |                                                                 |                                                   |                 |        |
| Patient ID:        | BSA:                                                            | Phone:                                            |                 |        |
| Diagnosis/subtype: |                                                                 |                                                   |                 |        |  
| PLEASE LABEL EACH TUBE WITH ACTUAL DATE AND TIME OF SAMPLE COLLECTION   |               |                                                               |        |        |                                                   |
|-------------------------------------------------------------------------|---------------|---------------------------------------------------------------|--------|--------|---------------------------------------------------|
| Day                                                                     | Time          | Instructions                                                  | Ideal  | Actual | Record comments (i.e., if collection missed), and |
| Time                                                                    | Time          | sign each time you collect a sample                           |        |        |                                                   |
| Day 1                                                                   | Prior to drug | PD 40X 6 mL NaHep x1 Label tube: sample number, date and time | ------ |        |                                                   |
| Administer XL184, Time:                                                 |               |                                                               |        |        |                                                   |