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NCT00585689 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT00585689 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 29 participants.
The verdict
NCT00585689, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. For this reason, researchers are focusing on new chemotherapy regimens to be given before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading. Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder cancer cells. ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated castor oil). However, these additives are felt to contribute to the side effects (possibly severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver more drug to tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being evaluated in other cancers in research studies. This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.
Interventions
- DRUG Carboplatin
- DRUG Gemcitabine
- PROCEDURE Radical Cystectomy
- DRUG ABI-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2007-12 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00585689
The ClinicalTrials.gov registry entry for NCT00585689 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT00585689 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00585689 about?
NCT00585689 is a clinical study titled "Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer". Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. For this reason, res...
What is the current status of trial NCT00585689?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2007-12. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00585689?
The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), Radical Cystectomy (PROCEDURE), ABI-007 (DRUG).
Who is sponsoring clinical trial NCT00585689?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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