Oxaliplatin Microdosing Assay in Predicting Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy

NCT02569723 | Completed Results DMC

• 3 other identifiers: 736253UCDCC#255P30CA093373
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies how well carbon C 14 oxaliplatin microdosing assay works in predicting exposure and sensitivity to oxaliplatin-based chemotherapy in patients with colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carbon C 14 is a radioactive form of carbon, exists in nature and in the body at a low level. Microdose carbon C 14 oxaliplatin diagnostic assay may help doctors understand how well patients respond to treatment and develop individualize oxaliplatin dosing in patients with colorectal cancer.

Conditions

Colon Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Feasibility of 14C Oxaliplatin Microdose as a Clinical Assay to Predict Oxaliplatin Exposure

  Correlate area under curve from phase 0 microdosing with area under curve for therapeutic dose of oxaliplatin

  0-5 minutes predose, 5, 15, and 30 minutes, and at 1, 2, 4, 8, and 24 hours after carbon C 14 oxaliplatin microdose

Secondary Outcomes (3)

• Duration of Disease Control (DDC) According to RECIST 1.1

  Up to 2 years

• Number of Participants With Adverse Events According to CTCAE Version 4

  Approximately 2 months

• Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Up to 2 years

Study Arms (1)

carbon C 14 oxaliplatin and oxaliplatin

EXPERIMENTAL

Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.

Drug: Carbon C 14 Oxaliplatin; Drug: Oxaliplatin

Interventions

Carbon C 14 Oxaliplatin DRUG

Intravenous infusion

Also known as: [14C] Oxaliplatin

carbon C 14 oxaliplatin and oxaliplatin

Oxaliplatin DRUG

Intravenous infusion

Also known as: Eloxatin

carbon C 14 oxaliplatin and oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed locally advanced or metastatic colon or rectal adenocarcinoma
• Intent to treat the patient with a leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) chemotherapy regimen containing fluorouracil (5-FU), leucovorin, and oxaliplatin according to clinical standard practice; the intent should be to dose oxaliplatin at 85 mg/m\^2 on an every 2 week basis
• Treatment with any additional Food and Drug Administration (FDA)-approved biologic agent (i.e. bevacizumab, cetuximab, or panitumumab) is allowed according to standard practice
• Prior radiation or surgery is allowed, but should be finished at least 2 weeks prior to study enrollment; if a participant has prior radiation therapy, at least one measurable lesion outside of the radiation field should be available for the evaluation of response to chemotherapy
• Any number of prior therapies other than oxaliplatin is allowed
• Zubrod performance status equal to or less than 2 (Karnofsky equal to or greater than 50%)
• Life expectancy of at least 3 months
• Absolute neutrophil count greater than or equal to 1,500/microL
• Platelets greater than or equal to 100,000/microL
• Total bilirubin less than 3 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase) less than or equal to 5 x ULN
• Creatinine less than 1.5 x ULN
• Women of child bearing potential must not be pregnant; a pre-study pregnancy test must be negative
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation
• Men must agree to use adequate contraception (barrier method or abstinence) prior to study entry and for 30 days after study participation

You may not qualify if:

• Prior treatment with oxaliplatin
• Patients must not receive concomitant radiation
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Participants who are pregnant or nursing
• Participants who are allergic to any platinum agent
• Participants who have more than grade 1 peripheral neuropathy

Sponsors & Collaborators

• Edward Kim: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Oxaliplatin

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Analyst
• Organization: University of California, Davis

nlogihara@ucdavis.edu

916-734-8053

Study Officials

• Edward Kim

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: October 7, 2015
• Study Start: October 16, 2015
• Primary Completion: April 20, 2018
• Study Completion: April 4, 2020
• Last Updated: March 30, 2021
• Results First Posted: March 30, 2021

Record last verified: 2021-03

Locations

US (1)