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NCT00639769 · ClinicalTrials.gov registry record · Phase 2
Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT00639769: Completed Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT00639769 is a Phase 2 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00639769, a Phase 2 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.
Primary Outcome
Number of patients in each response category according to RECIST criteria: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increas
Interventions
- DRUG cisplatin
- DRUG irinotecan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2002-02 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
What the finished NCT00639769 record still lists
NCT00639769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which cisplatin is the first listed.
NCT00639769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00639769 about?
NCT00639769 is a clinical study titled "Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer". RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: To determine if ...
What is the current status of trial NCT00639769?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2002-02. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00639769?
The interventions under investigation include: cisplatin (DRUG), irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00639769?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00639769's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 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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