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NCT00317772 · ClinicalTrials.gov registry record · Phase 1
Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT00317772: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00317772 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00317772, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purposes of this study are: 1. To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) weekly of topotecan in combination with standard dose gefitinib in patients with relapsed, platinum-resistant, ovarian, peritoneal or fallopian tube cancers that are epidermal growth factor receptor (EGF-R) positive (\>/= 1+). 2. To determine the response rate and response duration in this patient population treated with the maximum tolerated dose (MTD) of topotecan administered on a weekly schedule in combination with standard dose gefitinib, given by way of the mouth (PO) daily.
Primary Outcome
Dose-limiting toxicity defined as any Grade 4 hematological toxicity and any \> Grade 3 non-hematologic toxicity. The DLT (dose-limiting toxicity) is defined as any Grade 4 hematological toxicity and any \> Grade 3 non-hematologic toxicity.
Interventions
- DRUG Topotecan
- DRUG Gefitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2004-09-02 |
| Est. Completion | 2020-11-04 |
| Phase | Phase 1 |
What the finished NCT00317772 record still lists
NCT00317772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Topotecan is the first listed.
NCT00317772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00317772 about?
NCT00317772 is a clinical study titled "Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer". The purposes of this study are: 1. To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) weekly of topotecan in combination with standard dose gefitinib in patients with relapsed, platinum-resistant, ovarian, peritoneal or fallopian tube cancers that are epidermal growt...
What is the current status of trial NCT00317772?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2004-09-02. Estimated completion is 2020-11-04.
What interventions are being tested in trial NCT00317772?
The interventions under investigation include: Topotecan (DRUG), Gefitinib (DRUG).
Who is sponsoring clinical trial NCT00317772?
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 NCT00317772's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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