Colorectal Cancer Umbrella Protocol - Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC Program) Screening Protocol

The effectiveness of drugs used to treat colorectal cancer may be different from person to
person. Researchers want to learn if certain biomarkers can be used to help predict which
cancer drugs may work better than other drugs in different people with colorectal cancer.

Study Participation:

If you agree to take part in this study, the following tests and procedures will be
performed:

- A leftover sample of tumor tissue from a previous procedure, if available, will be used
for biomarker testing.

- Blood (about 3 tablespoons) will be drawn for biomarker testing, to check for levels of
cytokines (proteins that may affect the immune system), and to check the circulating
tumor cells (CTCs) in your blood.

- You will be asked how well you are able to perform the normal activities of daily living
(performance status).

You will also fill out a questionnaire about the cancer symptoms. This should take about 5
minutes.

Biomarker Test Results:

The study doctor and staff will review the biomarker test results with you.

If the results seem to show that a certain investigational drug may help to control the
cancer, and the drug is available through a separate MD Anderson clinical research study
called a "companion" drug study, your doctor may recommend that you have additional tests and
procedures performed. The tests and procedures will be performed as part of the companion
drug study to see if you are eligible to receive that drug. You will be asked to sign a
separate consent form for the companion drug study.

It is possible that the biomarker test results may seem to show that more than one drug may
help to control the cancer. If so, it may be possible that you could receive the other
drug(s) under other companion studies in the future. The study tests described below would be
repeated during those other studies as well.

Even if the biomarker testing shows that a certain drug may be helpful, it is possible that
you may not be eligible to take part in the separate companion drug study, the study drug may
not be available, or there may be other reasons you cannot take part in the drug study. You
may also decide that you do not want to take part in the companion drug study. Your doctor
will discuss other available treatment options with you.

Study Visits:

At study visits for this biomarker research study, the following tests and procedures will be
performed:

- You will fill out the cancer symptom questionnaire.

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for biomarker, cytokine, and CTC testing.

Your schedule of study visits will depend on whether or not you take part in a companion
study. There is a different schedule of visits for participants who do not take part in a
companion study but instead either take part in a clinical research study that is not a
companion study or they receive standard cancer drug(s).

If you take part in 1 or more companion studies, you will have study visits for this
biomarker research study on the following schedule:

- before you start taking the drug(s) if you join a companion drug study and it has been 2
or more weeks since you had these tests done (note: the amount of blood drawn will be
about 2 tablespoons at this visit)

- each time you return for imaging scans during the time that you take part in 1 or more
companion drug studies

- after you stop taking part in a companion drug study

If your first treatment after consenting to this biomarker research study is part of a
clinical research study that is not a companion study or if you receive standard cancer
drug(s), you will have study visits for this biomarker research study on the following
schedule:

- before you start taking the drug(s) during your first treatment period at MD Anderson
and it has been 2 or more weeks since you had these tests done (note: the amount of
blood drawn will be about 2 tablespoons at this visit)

- each time you return for imaging scans during your first treatment period at MD Anderson

- after you first stop taking part in a clinical research study that is not a companion
drug study, or until you first stop taking standard cancer drug(s).

Length of Treatment:

The study testing will continue:

- for as long as you are taking part in a companion drug study, or

- until you first stop taking part in a clinical research study that is not a companion
drug study, or until you first stop taking standard cancer drug(s), if you do not take
part in a companion drug study.

Follow-Up Visit:

If you stop taking part in this study:

- You will fill out the cancer symptom questionnaire.

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for biomarker, cytokine, and CTC testing.

Long-Term Follow-Up:

After your follow-up visit, from then on, the research staff will collect information on your
health status, the drug(s) you receive, and the status of the disease. This information may
be collected at the time of standard clinic visits, by reviewing your medical record and
imaging scans, and/or by contacting you by phone, mail, and/or email. If you are called, the
call will last about 10 minutes or less.

Inclusion Criteria:

1. The patient has a histologically or cytologically confirmed colorectal adenocarcinoma
with metastatic or unresectable, locally advanced disease documented on diagnostic
imaging studies.

2. The patient must have been previously treated with systemic chemotherapy for
metastatic or unresectable, locally advanced colorectal cancer, with no limit on the
number of prior regimens. Patients who develop recurrent or metastatic disease on or
within 6 months of adjuvant therapy are eligible.

3. Age >/=18 years to provide a uniform oncologic phenotype of adult-onset colorectal
cancer.

4. ECOG performance status 0-2.

5. The patient has signed informed consent.

Exclusion Criteria:

1) Inability to comply with study and/or follow-up procedures.