Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01064479 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT01064479: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01064479 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064479, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well combination chemotherapy with or without erlotinib hydrochloride works in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without erlotinib hydrochloride may be an effective treatment for squamous cell carcinoma of the head and neck.
Primary Outcome
Kaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals.
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Cisplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Erlotinib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2010-02-05 |
| Est. Completion | 2020-11-03 |
| Phase | Phase 2 |
What the finished NCT01064479 record still lists
NCT01064479 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01064479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01064479 about?
NCT01064479 is a clinical study titled "Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck". This randomized phase II trial studies how well combination chemotherapy with or without erlotinib hydrochloride works in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Drugs used in chemotherapy, such as docetaxel, ci...
What is the current status of trial NCT01064479?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2010-02-05. Estimated completion is 2020-11-03.
What interventions are being tested in trial NCT01064479?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Cisplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Erlotinib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01064479?
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 NCT01064479's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05285891 · 123 participants · Phase 4
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
- NCT05334368 · 123 participants · Phase 3
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
- NCT06088355 · 123 participants · NA
Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease
- NCT06111131 · 123 participants · NA
Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI