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NCT00068393 · ClinicalTrials.gov registry record · Phase 2
Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma
A Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT00068393: Completed Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
NCT00068393 is a Phase 2 study that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00068393, a Phase 2 study, has completed, sponsored by Eastern Cooperative Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving doxorubicin together with gemcitabine works in treating patients with locally recurrent or metastatic unresectable renal cell carcinoma (kidney cancer).
Primary Outcome
Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR
Interventions
- DRUG Doxorubicin
- DRUG Gemcitabine
- DRUG Neulasta
- DRUG G-CSF (granulocyte-colony stimulating factor)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2004-02-24 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT00068393 record still lists
NCT00068393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 4 interventions - of which Doxorubicin is the first listed.
NCT00068393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00068393 about?
NCT00068393 is a clinical study titled "Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma". RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving doxorubicin together with ge...
What is the current status of trial NCT00068393?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2004-02-24. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00068393?
The interventions under investigation include: Doxorubicin (DRUG), Gemcitabine (DRUG), Neulasta (DRUG), G-CSF (granulocyte-colony stimulating factor) (DRUG).
Who is sponsoring clinical trial NCT00068393?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00068393's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 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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