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NCT01711541 · ClinicalTrials.gov registry record · Phase 1
Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer
A Phase 1 study of Head and Neck Squamous Cell Carcinoma and Stage IVA Oropharyngeal Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 5
- Study locations
NCT01711541: Completed Phase 1 study of Head and Neck Squamous Cell Carcinoma and Stage IVA Oropharyngeal Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI).
NCT01711541 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Stage IVA Oropharyngeal Carcinoma AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01711541, a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Stage IVA Oropharyngeal Carcinoma AJCC v7, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 5
- Study locations
Study Summary
This partially randomized phase I/II trial studies the side effects and best dose of veliparib when given together with combination chemotherapy and to see how well they work in treating patients with stage IV head and neck cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective when given with or without veliparib in treating head and neck cancer.
Primary Outcome
Dose Limiting Toxicity (DLTs) will be assessed during the first cycle of induction chemotherapy. The following events are considered DLTs: Grade 4 neutropenia (ANC \< 500) lasting more than 14 days, Febrile neutropenia, Grade 4 thrombocytopenia, dose delay of greater than 3 weeks due to failure to recover counts, treatment-related grade 3 or grade 4 non-hematological toxicity (excluding alopecia, fatigue, hypersensitivity reaction, nausea, vomiting, constipation, diarrhea, hypokalemia, hypomagn
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Fluorouracil
- DRUG Hydroxyurea
- OTHER Laboratory Biomarker Analysis
Study Locations (5)
Illinois
- Northwestern University - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
- NorthShore University HealthSystem-Evanston Hospital - Evanston
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-10-22 |
| Est. Completion | 2023-05-15 |
| Phase | Phase 1 |
What the finished NCT01711541 record still lists
NCT01711541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01711541 lists 5 locations in 3 states (Illinois, Missouri, North Carolina).
Frequently Asked Questions
What is clinical trial NCT01711541 about?
NCT01711541 is a clinical study titled "Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer". This partially randomized phase I/II trial studies the side effects and best dose of veliparib when given together with combination chemotherapy and to see how well they work in treating patients with stage IV head and neck cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluoro...
What is the current status of trial NCT01711541?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-10-22. Estimated completion is 2023-05-15.
What conditions does trial NCT01711541 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Stage IVA Oropharyngeal Carcinoma AJCC v7, Stage IVB Oropharyngeal Carcinoma AJCC v7.
What interventions are being tested in trial NCT01711541?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Fluorouracil (DRUG), Hydroxyurea (DRUG), Laboratory Biomarker Analysis (OTHER).
Who is sponsoring clinical trial NCT01711541?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01711541 being conducted?
This trial has 5 study locations across Illinois, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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