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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief 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 Summary:

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.

Current Primary Outcome:

• TL [ Time Frame: Up to 6 months ]
  TL will be compared between participants experiencing at least 1 adverse event and those who experience none using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.
• Incidence of chemotherapy related grade 3 or higher adverse events, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 6 months ]
  Variance stabilizing and normalizing transformations will be applied to the data when appropriate. Descriptive statistics for participant characteristics, disease presentation, treatment related toxicity, treatment, duration of chemotherapy use, management of adverse events, and frequency of treatment discontinuation will be tabulated. TL will be compared between participants experiencing at least one adverse event and those who do not experience any adverse event using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.

Original Primary Outcome:

• Telomere length [ Time Frame: Up to 6 months ]
  TL will be compared between participants experiencing at least 1 adverse event and those who experience none using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.
• Incidence of chemotherapy related grade 3 or higher adverse events, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 6 months ]
  Variance stabilizing and normalizing transformations will be applied to the data when appropriate. Descriptive statistics for participant characteristics, disease presentation, treatment related toxicity, treatment, duration of chemotherapy use, management of adverse events, and frequency of treatment discontinuation will be tabulated. TL will be compared between participants experiencing at least one adverse event and those who do not experience any adverse event using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.

Current Secondary Outcome: Change in TL after chemotherapy [ Time Frame: Baseline to 6 months ]

Original Secondary Outcome: Change in telomere length after chemotherapy [ Time Frame: Baseline to 6 months ]

Dates:
Date Received: August 29, 2013
Date Started: October 2013
Date Completion: December 2017
Last Updated: January 25, 2017
Last Verified: January 2017