Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00468585 · ClinicalTrials.gov registry record · Phase 1
Study of Biweekly Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical Model
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT00468585: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00468585 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 62 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00468585, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
The purpose of this study is to find out what effects (both good and bad) that capecitabine has on you and your breast cancer when given in a novel schedule in combination with the antibody therapy, bevacizumab. Capecitabine (Xeloda®) is an anticancer drug that was approved by FDA in 1998 for treating metastatic breast cancer. Capecitabine is a pill that blocks the way cancer cells multiply and grow. Usually, this medicine is taken twice a day for fourteen days in a row. Patients then get a break from the drug for seven days. With this schedule and usual dose, some patients on capecitabine have experienced side effects that interfered with their daily comfort.Different doses and schedules of capecitabine have been studied in animal studies and in people with colon cancer. Mathematic modeling has been used to better understand these results.Information from these experiments leads us to ask if 7 days of treatment with capecitabine followed by a 7-day break is both safer and more active against breast cancer. The study you are considering is a first step in this direction and is designed to demonstrate both safety and activity. Bevacizumab is a biologic therapy that targets the growth of blood vessels which tumors need to grow. Women whose breast cancer spread to other parts of their bodies lived longer without their cancers growing when they were treated with bevacizumab and chemotherapy. Bevacizumab was tested with the 14-day/7-day schedule of capecitabine. These two medicines are safe when given together and seem to work better against breast cancer than capecitabine alone. This study is designed to answer the questions: 1. What are the side effects of bevacizumab and capecitabine when given in this different schedule and how often do they occur? 2. When given in this schedule, does capecitabine with bevacizumab help treat breast cancer that has spread or continues to grow despite being treated by other chemotherapy drugs before?
Interventions
- DRUG Bevacizumab
- DRUG Capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2005-06 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00468585
The ClinicalTrials.gov registry entry for NCT00468585 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT00468585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00468585 about?
NCT00468585 is a clinical study titled "Study of Biweekly Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical Model". The purpose of this study is to find out what effects (both good and bad) that capecitabine has on you and your breast cancer when given in a novel schedule in combination with the antibody therapy, bevacizumab. Capecitabine (Xeloda®) is an anticancer drug that was approved by FDA in 1998 for treati...
What is the current status of trial NCT00468585?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2005-06. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00468585?
The interventions under investigation include: Bevacizumab (DRUG), Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00468585?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
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, the data changelog, or report a data error.