Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
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ClinicalTrials.gov Identifier: NCT01437449 |
Recruitment Status :
Completed
First Posted : September 20, 2011
Results First Posted : December 17, 2019
Last Update Posted : December 17, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Drug: Docetaxel Drug: Cisplatin Drug: Cetuximab Drug: Carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With SCCHN |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | September 11, 2018 |
Actual Study Completion Date : | August 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Cisplatin + Docetaxel + Cetuximab
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
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Drug: Docetaxel
30 mg/m² by intravenous (IV) administration
Other Name: Taxotere Drug: Cisplatin 30 mg/m² by intravenous (IV) administration
Other Names:
Drug: Cetuximab 400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Other Name: Erbitux Drug: Carboplatin Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
Other Name: Paraplatin |
- 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.
- 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
- 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).
- 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) [ 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437449
United States, California | |
University of California Davis Medical Center | |
Davis, California, United States, 95616 | |
Stanford University, School of Medicine | |
Stanford, California, United States, 95305 |
Principal Investigator: | A. Dimitrios Colevas, MD | Stanford University |
Documents provided by A. Dimitrios Colevas, Stanford University:
Responsible Party: | A. Dimitrios Colevas, Professor of Medicine (Oncology) and Otolaryngology, Stanford University |
ClinicalTrials.gov Identifier: | NCT01437449 |
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 ) |
First Posted: | September 20, 2011 Key Record Dates |
Results First Posted: | December 17, 2019 |
Last Update Posted: | December 17, 2019 |
Last Verified: | December 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Quality of Life |
Head and Neck Neoplasms Neoplasms by Site Neoplasms Carboplatin Docetaxel Cetuximab |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |