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NCT00491075 · ClinicalTrials.gov registry record · Phase 2
Pemetrexed Plus Gemcitabine in Renal Cell Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00491075: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00491075 is a Phase 2 study that was terminated before completion, run by M.D. Anderson 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
NCT00491075, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Primary Objective: * To determine the clinical activity of Pemetrexed + Gemcitabine in non-clear cell renal cell cancer (RCC). Clinical activity will take into account response rate and progression free survival (PFS). Secondary Objectives: * To determine the toxicity of Pemetrexed + Gemcitabine in non-clear cell RCC. * To estimate the survival rate of patients with non-clear cell RCC treated with this combination.
Primary Outcome
Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: \>20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or \> new lesions; Stable Disease: Insufficient shrinkage for partial response
Interventions
- DRUG Pemetrexed
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2005-12 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
Why NCT00491075 stopped before completion
NCT00491075 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 2 interventions - of which Pemetrexed is the first listed.
NCT00491075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00491075 about?
NCT00491075 is a clinical study titled "Pemetrexed Plus Gemcitabine in Renal Cell Cancer". Primary Objective: * To determine the clinical activity of Pemetrexed + Gemcitabine in non-clear cell renal cell cancer (RCC). Clinical activity will take into account response rate and progression free survival (PFS). Secondary Objectives: * To determine the toxicity of Pemetrexed + Gemcitabine ...
What is the current status of trial NCT00491075?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2005-12. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00491075?
The interventions under investigation include: Pemetrexed (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT00491075?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00491075'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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