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Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
Cetuximab
Carboplatin
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Quality of Life

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis Medical Center
  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cisplatin + Docetaxel + Cetuximab

Arm Description

Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
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. Complete Response (CR) = Disappearance of all target lesions Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria

Secondary Outcome Measures

Progression-free Survival (PFS)
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). Complete Response (CR) = Disappearance of all target lesions Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria
Overall Survival (OS)
Overall survival (OS) was assessed through 24 months. The outcome is reported as the median time that participants remained alive, with 95% CI.
Grade 3, 4, and 5 Related Adverse Events (Toxicities)
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.

Full Information

First Posted
September 16, 2011
Last Updated
December 3, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01437449
Brief Title
Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Official Title
Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With SCCHN
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Docetaxel and cetuximab are FDA-approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Cisplatin and carboplatin, while not FDA-approved for SCCHN, have been used as standard of care in SCCHN patients in combination with other drugs. This study evaluates if weekly cisplatin and docetaxel, in combination with cetuximab, is effective in palliative treatment of patients with SCCHN. These drugs will be given intravenously weekly, repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse events.
Detailed Description
Primary Objective:To establish the response rate using RECIST 1 criteria to weekly TPC in patients with metastatic or relapsed squamous cell carcinoma of the head and neck Secondary Objective: To establish the safety profile, progression free and overall survival of weekly TPC in this patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin + Docetaxel + Cetuximab
Arm Type
Experimental
Arm Description
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
30 mg/m² by intravenous (IV) administration
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Cisplatinum, Platinol
Intervention Description
30 mg/m² by intravenous (IV) administration
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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. Complete Response (CR) = Disappearance of all target lesions Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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). Complete Response (CR) = Disappearance of all target lesions Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria
Time Frame
24 months
Title
Overall Survival (OS)
Description
Overall survival (OS) was assessed through 24 months. The outcome is reported as the median time that participants remained alive, with 95% CI.
Time Frame
24 months
Title
Grade 3, 4, and 5 Related Adverse Events (Toxicities)
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Dimitrios Colevas, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Medical Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
95305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29540603
Citation
Trieu V, Pinto H, Riess JW, Lira R, Luciano R, Coty J, Boothroyd D, Colevas AD. Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck. Oncologist. 2018 Jul;23(7):764-e86. doi: 10.1634/theoncologist.2017-0618. Epub 2018 Mar 14.
Results Reference
result

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Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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