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NCT01009203 · ClinicalTrials.gov registry record · Phase 2
Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma
A Phase 2 study, sponsored by New Mexico Cancer Research Alliance.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT01009203: Clinical Trial Phase 2 study, sponsored by New Mexico Cancer Research Alliance.
NCT01009203 is a Phase 2 study that was terminated before completion, run by New Mexico Cancer Research Alliance. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01009203, a Phase 2 study, was terminated before completion, sponsored by New Mexico Cancer Research Alliance.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary hypothesis of this study is that the addition of mammalian target of rapamycin (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN), consistent with preclinical xenograft data. Patients will be treated with the combination of temsirolimus and erlotinib, at the previously established Maximal Tolerated Dose (MTD). The primary signal of efficacy will be progression free survival (PFS), anticipating that PFS will be prolonged compared to historical PFS in SCCHN patients treated with erlotinib or cetuximab monotherapy.
Primary Outcome
The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease wit
Interventions
- DRUG Temsirolimus
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
Why NCT01009203 stopped before completion
NCT01009203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Temsirolimus is the first listed.
NCT01009203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01009203 about?
NCT01009203 is a clinical study titled "Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma". The primary hypothesis of this study is that the addition of mammalian target of rapamycin (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN), consistent with preclinica...
What is the current status of trial NCT01009203?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2009-12. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01009203?
The interventions under investigation include: Temsirolimus (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT01009203?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01009203's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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