- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01437449
Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With SCCHN
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Davis, California, United States, 95616
- University of California Davis Medical Center
-
Stanford, California, United States, 95305
- Stanford University, School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
INCLUSION CRITERIA
- Squamous cell carcinoma (SCC) of head and neck (SCCHN), including all pharynx, larynx, oral cavity, skin and para-nasal sinus sites. Patients with SCC of unknown primary presenting in the neck clinically compatible with head and neck mucosal primary sites are eligible.
- If prior chemoradiation, radiation, and/or surgery in the potentially curative setting, > 3 months has elapsed since the end of the potentially curative treatment ended
- If history of other malignancies treated curatively > 1 year prior to enrollment, no evidence of relapse at the time of enrollment
- If brain metastasis, central nervous system (CNS) imaging documents no evidence of CNS progression at least 30 days following definitive CNS treatment (resection or radiation)
- ≥ 16 years old
- Eastern cooperative oncology group (ECOG) Performance Status < 3
- Laboratory value requirements at enrollment:
- Absolute neutrophil count > 1500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 8 g/dL
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) unless liver metastases documented. If so, AST and ALT < 5 x ULN required.
- Total bilirubin < 1.5 x ULN, EXCEPT if Gilbert's syndrome is present. If so, total bilirubin < 2.5 x ULN
- Serum Creatinine < 1.5 mg/dL OR an estimated creatinine clearance from 24 hour urine collection > 50 mL/min
- Peripheral neuropathy < grade 2
- Hearing loss in best ear < grade 2 per Chang criteria if audiogram performed. Formal audiology is not required in patients with no clinical evidence of hearing loss at baseline.
- Ability to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA
- Prior palliative chemotherapy
- Active infections including HIV (EXCEPTION: HIV-positive patients on HAART with undetectable blood HIV levels, or with history or serological evidence of exposure to Hepatitis B without active infection are eligible)
- Prior grade 3 allergic or infusion reactions to docetaxel, cisplatin or cetuximab (EXCEPTION: a history of infusion reactions that were well-tolerated, at physician's discretion)
- Pregnant and/or lactating
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cisplatin + Docetaxel + Cetuximab
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
|
30 mg/m² by intravenous (IV) administration
Other Names:
30 mg/m² by intravenous (IV) administration
Other Names:
400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Other Names:
Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: 8 weeks
|
Clinical response for each participant will be assessed after 8 weeks of treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Overall response rate (ORR) was assessed as the sum of the number of participants that experience a complete response (CR) or partial response (PR). The outcome is defined and reported as the number of subjects that responded, a number without dispersion. Other response statuses are included. RECIST v1.1 criteria is defined as follows.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: 24 months
|
Progression-free survival (PFS), defined as the duration of time from start of treatment to time of progression or death, was assessed through 24 months, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The outcome is reported as the median time that participants remained free of progression, with 95% confidence interval (CI).
|
24 months
|
Overall Survival (OS)
Time Frame: 24 months
|
Overall survival (OS) was assessed through 24 months.
The outcome is reported as the median time that participants remained alive, with 95% CI.
|
24 months
|
Grade 3, 4, and 5 Related Adverse Events (Toxicities)
Time Frame: 2 years
|
Related adverse events are considered toxicities.
The outcome was assessed as adverse events and serious adverse events (SAEs per 21CFR§312.32)
at least Grade 3, and are reported as the number of toxicities by grade (3, 4 or 5), a number without dispersion.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: A. Dimitrios Colevas, MD, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-22329
- SU-08222011-8290 (Other Identifier: Stanford University Medical Center)
- NCI-2011-03271 (Other Identifier: CTRP)
- ENT0033 (Other Identifier: OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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