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NCT00995488 · ClinicalTrials.gov registry record · Phase 2
Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00995488: Clinical Trial Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT00995488 is a Phase 2 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00995488, a Phase 2 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of patients with advanced bladder cancer. Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based chemotherapy in this setting has activity but is not curative. Furthermore, patients with this disease have comorbidities that limit the use of cisplatin based therapy. Combination paclitaxel, carboplatin and gemcitabine is active and well tolerated in this patient population. Paclitaxel is formulated with ethanol and a Cremophor EL (polyoxyethylated castor oil) which contribute to the side effects associated with paclitaxel. ABI-007 (brand name Abraxane™) is a form of paclitaxel that 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 based on superior anticancer effect, and is being evaluated in other cancers in research studies.
Primary Outcome
Clinical efficacy of ABI-007 based therapy will be determined by the overall response rate (Partial Response \[PR\] + Complete Response\[CR\]) to therapy. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Complete Response: Disappearance of all target lesions.
Interventions
- DRUG ABI-007 (Abraxane®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
Why NCT00995488 stopped before completion
NCT00995488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which ABI-007 (Abraxane®) is the first listed.
NCT00995488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00995488 about?
NCT00995488 is a clinical study titled "Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer". This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of patients with advanced bladder cancer. Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based chemotherapy in this setting has activity ...
What is the current status of trial NCT00995488?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2009-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00995488?
The interventions under investigation include: ABI-007 (Abraxane®) (DRUG).
Who is sponsoring clinical trial NCT00995488?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00995488's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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