Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers

PRIMARY OBJECTIVES:

I. Detection of mutated Kras in urine specimen of patients with Kras mutated metastatic colon
cancer on first, second, or third line therapy.

II. Detection of new Kras in urine in patients without Kras mutated metastatic colon cancer
on therapy which includes anti-EGFR antibodies (cetuximab or panitumumab).

SECONDARY OBJECTIVES:

I. Changes of the stool microbiome with chemotherapy and at progression of the disease.

DESCRIPTIVE OBJECTIVES:

I. Changes in the quantity of mutated Kras, Braf or PI3K in urine deoxyribonucleic acid (DNA)
over the cycles of first line therapy.

II. Associations between the quantity of mutated Kras, Braf or PI3K in urine DNA, molecular
make up of circulating tumor cells (CTCs), cell free DNA and progression over the course of
first line therapy.

III. Feasibility of detection of exosome in the plasma of colorectal cancer patients on first
line chemotherapy in Dr. Fabbri?s lab at Children?s Hospital Los Angeles.

IV. Feasibility of detection of tumor DNA in the plasma of colorectal cancer patients on
first line chemotherapy.

OUTLINE:

Participants undergo collection of blood and urine at baseline, on day 1 of courses 1, 2, and
3, at restaging, and at disease progression. Participants may undergo collection of stool at
baseline, on day 1 of course 2, and at disease progression. Participants also undergo biopsy
within 4 weeks of disease progression.

Inclusion Criteria:

- All patients with metastatic/unresectable colorectal cancer who will undergo first,
second, or third line therapy; the participating investigator will select treatment,
however, patients with Kras wild type must receive anti-EGFR therapy to be eligible
for this study

- Subject consent to enrollment on the protocol

- Histologically confirmed metastatic or un-resectable colorectal cancer, known Kras
status; knowledge of other mutations is optional

- Willingness to undergo biopsy at the time of progression

- Willingness to follow the study instructions for collection of specimens

- Available archival tissue