Gut Microbiome in Fecal Samples From Patients With Metastatic Cancer Undergoing Chemotherapy or Immunotherapy

Stage IV Colorectal Cancer Clinical Trial

Official title:

The Role of Microbiome in Cancer Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02960282
• Other study ID #: 0S-16-9
• Secondary ID: NCI-2016-015840S
• Status: Terminated
• Start date: October 20, 2016
• Est. completion date: April 13, 2022

Study information

• Verified date: August 2022
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research trial studies the gut microbiome in fecal samples from patients with cancer that has spread to other parts of the body who are undergoing chemotherapy or immunotherapy. Studying samples of feces from patients with metastatic cancer in the laboratory may help doctors learn if the make-up of the gut microbiome has a positive or negative influence to a patient's response to chemotherapy or immunotherapy.

Description:

PRIMARY OBJECTIVES:

I. To quantitatively determine the composition of the microflora and their gene and protein expression levels in patients with metastatic colorectal cancer being treated with fluorouracil (5-FU) based chemotherapy, or anti-PD1 immunotherapy.

SECONDARY OBJECTIVES:

I. Compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with response to chemotherapy or immunotherapy.

II. Compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with toxicities and side effects resulting with chemotherapy or immunotherapy.

OUTLINE:

Patients undergo collection of fecal specimens at baseline, prior to start of each course of chemotherapy or immunotherapy, at the end of weeks 2, 4, 6, and 8, at the end of course 3 and courses thereafter of chemotherapy or immunotherapy, and at the time of disease progression or going off-treatment. Fecal specimens are analyzed via 16S ribosomal ribonucleic acid (RNA) gene sequencing, meta-transcriptomics analysis, and meta-proteomics analysis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: April 13, 2022
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be willing and able to provide fecal samples according to protocol schedule

• COHORT A

• Diagnosis of metastatic colorectal cancer, where the metastatic disease has not been previously treated

• Scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or folinic acid-fluorouracil-irinotecan (FOLFIRI) based chemotherapy for the advanced disease

• Must have radiologic evidence of disease

• COHORT B

• Diagnosis of metastatic cancer

• Scheduled to begin pembrolizumab or another anti-PD-1 or anti-PD-L1 antibody as single agent therapy for the treatment of the advanced disease

• Must have physical or radiologic evidence of disease

Exclusion Criteria:

• Patients with a colostomy or any other issues that may prevent the standard methods for collection of stool are not eligible for this study

• Patients are not enrolled or a research protocol for treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Carcinoma
• Stage IV Colorectal Cancer
• Stage IVA Colorectal Cancer
• Stage IVB Colorectal Cancer

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of fecal specimens

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best tumor response, defined as a complete response or a clear decrease in tumor burden	The presence and amounts of species and their protocols will be compared to tumor response.	Up to 2 years