N/A
Completed N=6
Oxaliplatin Microdosing Assay in Predicting Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy
Colon Adenocarcinoma
Source: ClinicalTrials.gov NCT02569723 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Feasibility of 14C Oxaliplatin Microdose as a Clinical Assay to Predict Oxaliplatin Exposure — 0.63 R squared
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of 14C Oxaliplatin Microdose as a Clinical Assay to Predict Oxaliplatin Exposure |
0.63 | — |
| SECONDARY Duration of Disease Control (DDC) According to RECIST 1.1 |
— | — |
| SECONDARY Number of Participants With Adverse Events According to CTCAE Version 4 |
1; 1; 1; 2; 1; 3 | — |
| SECONDARY Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Ability to understand and willing to sign a written informed consent document
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02569723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.