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

Stopped early

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01934179

Run by

Fox Chase Cancer Center

People needed

6

Starts

2013-10-01

Expected to finish

2015-09-11

Last updated by the study team

2018-02-07

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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