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NCT00231465 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT00231465: Completed Phase 2 study of Non-Small Cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00231465 is a Phase 2 study of Non-Small Cell Lung Cancer that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 44 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00231465, a Phase 2 study of Non-Small Cell Lung Cancer, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients with prior adjuvant chemotherapy were allowed to enroll on this trial.
Primary Outcome
ORR: Complete Response (CR) + Partial Response (PR). Response rate for Elderly (\> 70 years) previously untreated patients with Stage IIIb (With Malignant Pleural Effusion (MPE)) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): \* Complete Response (CR)- Disappearance of all target lesions; \* Partial Response (PR)- At least a 30% decrease in
Conditions Studied
Interventions
- DRUG docetaxel (Taxotere®)
- DRUG ZD1839
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2003-07 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00231465 record still lists
NCT00231465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which docetaxel (Taxotere®) is the first listed.
NCT00231465 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00231465 about?
NCT00231465 is a clinical study titled "Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer". This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients with prior adjuvant chemotherapy were allowed to enroll on this trial.
What is the current status of trial NCT00231465?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2003-07. Estimated completion is 2012-08.
What conditions does trial NCT00231465 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT00231465?
The interventions under investigation include: docetaxel (Taxotere®) (DRUG), ZD1839 (DRUG).
Who is sponsoring clinical trial NCT00231465?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00231465 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00231465's enrollment target sits among peer trials
44 345th of 454 higher than 107 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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