Telomere Length in Predicting Toxicity in Older Patients With Stage III-IV Colorectal Cancer Undergoing Chemotherapy

PRIMARY OBJECTIVES:

I. To determine the relationship between pre-treatment telomere length (TL) and rate of grade
3 or higher adverse events occurring on front line leucovorin calcium, fluorouracil, and
oxaliplatin (FOLFOX)-based chemotherapy among patients over the age of 70 with early stage or
metastatic colorectal cancer (CRC).

SECONDARY OBJECTIVES:

I. To evaluate the impact of the FOLFOX-based chemotherapy treatment on peripheral blood
lymphocyte telomere length.

II. To evaluate the association between pre-treatment geriatric assessment tools scores,
telomere length, and the incidence of chemotherapy related adverse events among older early
stage or metastatic CRC patients.

TERTIARY OBJECTIVES:

I. To evaluate the association between pre-treatment levels of serum interleukin-6 (IL-6),
C-reactive protein (CRP) and D-dimer and incidence of chemotherapy related adverse events.

II. To evaluate the correlation between pre-treatment telomere length, levels of other
biomarkers of aging (IL6, CRP, D-dimer), and rates of adverse events with FOLFOX-based
chemotherapy.

OUTLINE:

Patients undergo blood sample collection for analysis via real-time polymerase chain reaction
(PCR) at baseline, 3 months, and 6 months.

After completion of study, patients are followed up every 3 months for up to 2 years.

Inclusion Criteria:

- Both men and women of all races and ethnic groups are eligible for this trial

- Patients must have histologically or cytologically confirmed adenocarcinoma of the
colon or rectum that is stage III or IV and has not been treated with systemic
chemotherapy (biopsy of metastatic site not required if primary tumor biopsied and
clinical scenario is consistent with metastatic disease)

- Patients must be deemed eligible for systemic chemotherapy with FOLFOX6 +/-
bevacizumab at full standard doses

- For patient with metastatic disease, previous adjuvant chemotherapy is allowed as long
it was completed at least 12 months prior to study enrollment and did not include
oxaliplatin

- Prior radiation therapy is allowed but must have been completed >= 4 weeks prior to
study entry

- Eastern Cooperative Oncology Group (ECOG) performance status < 2

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits, or creatinine clearance >= 50
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Patients must demonstrate ability to understand and the willingness to sign a written
informed consent document

- Patients must demonstrate ability to complete study questionnaires

- Patients must provide written informed consent and Health Insurance Portability and
Accountability Act (HIPAA) consent prior to performance of study-specific procedures
or assessments and must be willing to comply with treatment and follow up

- Male participants with female partners who are of childbearing potential must agree to
use an acceptable and effective method of contraception

Exclusion Criteria:

- Patients with metastatic disease who have had adjuvant chemotherapy with oxaliplatin
within 12 months of enrollment (single agent fluorouracil [5FU] or capecitabine is
allowed) or radiotherapy within 4 weeks prior to entering the study

- Patients with known brain metastases should be excluded from this clinical trial

- Patients with a known history of allergic reactions attributed to compounds of similar
chemical or biologic composition to the agents used in the study

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection-requiring intravenous (IV) antibiotics, symptomatic congestive heart
failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements

- Known human immunodeficiency virus (HIV)-positive patients and those with known
hepatitis B or C are excluded from the study

- Patients with evidence of other cancer within 5 years, excluding adequately treated
basal cell carcinoma of the skin