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NCT00778167 · ClinicalTrials.gov registry record · Phase 1
Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 1 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT00778167: Completed Phase 1 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, sponsored by National Cancer Institute (NCI).
NCT00778167 is a Phase 1 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 689-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00778167, a Phase 1 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether erlotinib hydrochloride is more effective when given together with or without cixutumumab in treating non-small cell lung cancer.
Primary Outcome
Patients were evaluable for cohort dose escalation/de-escalation decision making either if they experienced DLTs in cycle 1 or if they had completed 24 of the planned 28 days (85%) dosing of erlotinib and three of the four planned days of weekly dosing of cixutumumab (75%) in cycle 1 in cohorts 1 and 2 in the absence of DLTs. In cohort 3, patients were evaluable for tolerability if they had completed 18 days (85%) dosing of erlotinib and had received the planned day 1 dose of cixutumumab.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG erlotinib hydrochloride
- BIOLOGICAL cixutumumab
Study Locations (2)
Colorado
- University of Colorado - Denver
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-10 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT00778167 record still lists
NCT00778167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 689-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Stage IV Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT00778167 reports a single indexed study location in Colorado, New York.
Frequently Asked Questions
What is clinical trial NCT00778167 about?
NCT00778167 is a clinical study titled "Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer". This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop th...
What is the current status of trial NCT00778167?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-10. Estimated completion is 2012-05.
What conditions does trial NCT00778167 study?
This clinical trial studies the following conditions: Stage IV Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT00778167?
The interventions under investigation include: laboratory biomarker analysis (OTHER), erlotinib hydrochloride (DRUG), cixutumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00778167?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00778167 being conducted?
This trial has 2 study locations across Colorado, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00778167's enrollment target sits among peer trials
18 19th of 23 higher than 5 of 23 other Stage IV Non-small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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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