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

Temple University Health System (TUHS)

Status

Terminated

Conditions

Stage IIIA Colon Cancer

Signet Ring Adenocarcinoma of the Colon

Signet Ring Adenocarcinoma of the Rectum

Mucinous Adenocarcinoma of the Colon

Stage IIIB Colon Cancer

Stage IIIC Colon Cancer

Stage IV Rectal Cancer

Stage IIIB Rectal Cancer

Stage IIIC Rectal Cancer

Mucinous Adenocarcinoma of the Rectum

Stage IV Colon Cancer

Stage IIIA Rectal Cancer

Treatments

Other: questionnaire administration

Other: laboratory biomarker analysis

Other: cytology specimen collection procedure

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT01934179

P30CA006927 (U.S. NIH Grant/Contract)

ERP-GI-049

13-020

NCI-2013-01415 (Registry Identifier)

GI-049 (Other Identifier)

Details and patient eligibility

About

This pilot research trial studies telomere length in predicting toxicity in older patients with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and predict how well patients will respond to treatment.

Full description

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.

Enrollment

6 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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