Overview

This trial is active, not recruiting.

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
Treatments cytology specimen collection procedure, laboratory biomarker analysis, questionnaire administration
Sponsor Fox Chase Cancer Center
Collaborator National Cancer Institute (NCI)
Start date October 2013
End date September 2015
Trial size 6 participants
Trial identifier NCT01934179, 13-020, ERP-GI-049, GI-049, NCI-2013-01415, P30CA006927

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients undergo blood collection for analysis via real-time PCR at baseline, 3 months, and 6 months.
cytology specimen collection procedure cytologic sampling
Undergo blood sample collection
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
TL
time frame: Up to 6 months
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

Secondary Outcomes

Measure
Change in TL after chemotherapy
time frame: Baseline to 6 months

Eligibility Criteria

Male or female participants at least 70 years old.

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

Additional Information

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
Principal investigator Efrat Dotan
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Fox Chase Cancer Center.
Location data was received from the National Cancer Institute and was last updated in March 2016.