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

NCT01934179 | Terminated

• 5 other identifiers: ERP-GI-049NCI-2013-0141513-020GI-049P30CA006927
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• TL

  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.

  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

  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.

  Up to 6 months

Secondary Outcomes (1)

• Change in TL after chemotherapy

  Baseline to 6 months

Other Outcomes (1)

• Association of each geriatric scale, and pro-inflammatory markers to the incidence of chemotherapy related adverse events and TL

  Up to 6 months

Study Arms (1)

Ancillary-correlative (real-time PCR)

Patients undergo blood collection for analysis via real-time PCR at baseline, 3 months, and 6 months.

Other: cytology specimen collection procedure; Other: laboratory biomarker analysis; Other: questionnaire administration

Interventions

cytology specimen collection procedure OTHER

Undergo blood sample collection

Also known as: cytologic sampling

Ancillary-correlative (real-time PCR)

laboratory biomarker analysis OTHER

Correlative studies

Ancillary-correlative (real-time PCR)

questionnaire administration OTHER

Ancillary studies

Ancillary-correlative (real-time PCR)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer Center

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

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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Efrat Dotan

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: October 1, 2013
• Primary Completion: September 11, 2015
• Study Completion: September 11, 2015
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

US (1)