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NCT00480584 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of Capecitabine in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00480584: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00480584 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00480584, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a phase I clinical trial examining the safety, feasibility, and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine once per week for 3 weeks, followed by a week off treatment. Erlotinib (tablet) taken by mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period. An accelerated dose-escalation scheme will be employed with 4 planned dose levels. Whenever patients have been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended phase II dose (RPTD) to confirm tolerability at that dose. In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles or until disease progression and patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity.
Primary Outcome
The Maximum-tolerated dose (of capecitabine) is determined as the dose level at which two or more of six patients experience dose-limiting toxicity. The MTD will not exceed 1250 mg/m2.
Interventions
- DRUG gemcitabine
- DRUG capecitabine
- DRUG erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-04 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT00480584 record still lists
NCT00480584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which gemcitabine is the first listed.
NCT00480584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00480584 about?
NCT00480584 is a clinical study titled "A Phase I Trial of Capecitabine in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer". This is a phase I clinical trial examining the safety, feasibility, and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Treatment will be administered at Moffitt on an out...
What is the current status of trial NCT00480584?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2007-04. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00480584?
The interventions under investigation include: gemcitabine (DRUG), capecitabine (DRUG), erlotinib (DRUG).
Who is sponsoring clinical trial NCT00480584?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00480584's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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