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NCT01261299 · ClinicalTrials.gov registry record · Early Phase 1
Clinical Study of Microdosing Carboplatin in Lung or Bladder Cancer
A Early Phase 1 study, sponsored by University of California, Davis.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 21
- Enrollment target
NCT01261299: Clinical Trial Early Phase 1 study, sponsored by University of California, Davis.
NCT01261299 is a Early Phase 1 study that was terminated before completion, run by University of California, Davis. The registered enrollment target is 21 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01261299, a Early Phase 1 study, was terminated before completion, sponsored by University of California, Davis.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Carboplatin kills cancer cells mainly through induction of DNA damage (drug-DNA adducts). The goal of this clinical trial is to determine if chemoresistance to carboplatin can be identified by measuring carboplatin-induced DNA monoadducts, the precursor of Pt-DNA diadducts or crosslinks, from subtherapeutic drug doses given prior to the initiation of chemotherapy. We hypothesize that low levels of carboplatin-DNA monoadducts and rapid drug-DNA adduct repair correlate with chemoresistance. A highly sensitive technology, called accelerator mass spectrometry (AMS), will be used to measure carboplatin-DNA monoadducts from patient samples. AMS can measure C-14 at the attomole level in specimens of milligram size. In this study, patients will receive one non-toxic "microdose" (defined as 1/100th the therapeutic dose) of C-14-labeled carboplatin. Blood specimens will be drawn for determination of carboplatin-DNA monoadduct formation and repair in peripheral blood mononuclear cells (PBMC), and pharmacokinetics (PK) will be determined from serum ultrafiltrate. In patients microdosed prior to providing tumor samples, a few milligrams of leftover tumor biopsy/resection specimens will be analyzed for formation of carboplatin-DNA monoadducts. Patients will subsequently receive carboplatin-based chemotherapy. The levels of microdose-induced carboplatin-DNA monoadducts will be correlated with response to chemotherapy. Some blood and biopsy samples will be assayed by RT-PCR for several putative resistance markers at the mRNA level. Side effects will also be monitored and compared to the AMS data. This trial will also utilize PK, DNA repair and pharmacogenomics data in order to determine some of the underlying chemoresistance mechanisms.
Primary Outcome
Imaging studies (including CT, MRI, PET/CT and CXR) and cystoscopy will be performed to evaluate the response. The RECIST 1.1 will be used to determine the cancer response. Tumor response, including complete response (CR, or complete disappearance) or partial response (PR, at least a 30% decrease of target lesion) will be correlated with the patient's carboplatin-DNA monoadduct levels.
Interventions
- DRUG Carbon-14-labeled carboplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-12 |
| Est. Completion | 2016-11 |
| Phase | Early Phase 1 |
Why NCT01261299 stopped before completion
NCT01261299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Carbon-14-labeled carboplatin is the first listed.
NCT01261299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01261299 about?
NCT01261299 is a clinical study titled "Clinical Study of Microdosing Carboplatin in Lung or Bladder Cancer". Carboplatin kills cancer cells mainly through induction of DNA damage (drug-DNA adducts). The goal of this clinical trial is to determine if chemoresistance to carboplatin can be identified by measuring carboplatin-induced DNA monoadducts, the precursor of Pt-DNA diadducts or crosslinks, from subthe...
What is the current status of trial NCT01261299?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2010-12. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01261299?
The interventions under investigation include: Carbon-14-labeled carboplatin (DRUG).
Who is sponsoring clinical trial NCT01261299?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01261299's enrollment target sits among peer trials
21 1130th of 2000 higher than 844 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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