Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00216437 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study Combining Oral Capecitabine (Xeloda) and Radiotherapy for Patients With Unresectable Liver or Cholangiocarcinoma
A Phase 1 study, sponsored by James A. Haley Veterans Administration Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00216437 is a Phase 1 study that was terminated before completion, run by James A. Haley Veterans Administration Hospital. The registered enrollment target is 30 participants.
The verdict
NCT00216437, a Phase 1 study, was terminated before completion, sponsored by James A. Haley Veterans Administration Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Our long-term working hypothesis is that if 3-D radiation is combined with the effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. The primary objective is to determine the maximum tolerated dose of capecitabine used along with 3-D conformal radiation therapy. Capecitabine will be taken by mouth each day of radiation. The total daily dose should be taken as two divided doses approximately 12 hours apart, within 30 minutes after eating, ideally after breakfast and the evening meal. The overall total number of patients expected to participate in this study could be as high as 30 depending on how the treatment is tolerated. The first group (3-6 patients) on the study will receive the drug (Xeloda®) at 600mg/m² (level 1) and radiation. If the first group does well, the second group of patients on the study (3-6 patients) will receive 825 mg/m² (level 2) and radiation. If the second group does well, the third group will receive 1,000 mg/m² (level 3) and radiation. If the first dose level of 600mg/m² is NOT tolerated, we will reduce the dose to 500mg/m² and enroll another 3-6 patients at the lower dose. After the highest tolerated dose is identified, 12 additional patients will be treated at that dose to further test the safety of the treatment and better understand the effects of the treatment on disease with more patients. The following tests and procedures are part of regular medical treatment (standard care) for the disease and are also required for this study. * physical examinations * blood tests including pregnancy test * urinalysis * ECG (heart tracing) * chest X-ray * CT scan of the abdomen Follow-up visits are done 1 month after radiation, then 3 months later, then every 3 months for 2 years.
Interventions
- DRUG Capecitabine (Xeloda)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-12 |
| Est. Completion | 2007-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00216437
The ClinicalTrials.gov registry entry for NCT00216437 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James A. Haley Veterans Administration Hospital, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Capecitabine (Xeloda) is the first listed.
NCT00216437 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00216437 about?
NCT00216437 is a clinical study titled "Dose Escalation Study Combining Oral Capecitabine (Xeloda) and Radiotherapy for Patients With Unresectable Liver or Cholangiocarcinoma". Our long-term working hypothesis is that if 3-D radiation is combined with the effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. The primary objective is to determine the maximum tolerated dose of capecitabine used along with 3-D confo...
What is the current status of trial NCT00216437?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2004-12. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00216437?
The interventions under investigation include: Capecitabine (Xeloda) (DRUG).
Who is sponsoring clinical trial NCT00216437?
This trial is sponsored by James A. Haley Veterans Administration Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.