NCT01934179

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

Pilot Study Assessing the Correlation Between Telomere Length and Chemotherapy- Related Toxicity Among Early Stage and Metastatic Colorectal Patients Over the Age of 70

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Mucinous Adenocarcinoma of the Colon
• Mucinous Adenocarcinoma of the Rectum
• Signet Ring Adenocarcinoma of the Colon
• Signet Ring Adenocarcinoma of the Rectum
• Stage IIIA Colon Cancer
• Stage IIIA Rectal Cancer
• Stage IIIB Colon Cancer
• Stage IIIB Rectal Cancer
• Stage IIIC Colon Cancer
• Stage IIIC Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Interventions

Type	Name	Description
OTHER	cytology specimen collection procedure	Undergo blood sample collection
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-09-11
• Completion: 2015-09-11
• First posted: 2013-09-04
• Last updated: 2018-02-07

Locations

1 site across 1 country: United States