Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Fluorouracil

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

5-Fluorouracil

Marshall Posner, MD

The purpose of this study is to determine the appropriate dose, that dose which is found to give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications.

* Treatment begins with a one hour infusion of docetaxel followed by a 1/2 hour infusion of cisplatin. 5-fluorouracil will be administered through continuous IV infusion through a portable pump for four days at home. A cycle is twenty-one days long ( 4 days of chemotherapy and 17 days of recovery).
* During each cycle blood tests will be performed weekly. A physical exam will be performed and the impact of the chemotherapy will be assessed at the end of each cycle.
* If after 2 cycles the patients cancer has not responded sufficiently they will be removed from the study.
* If significant reduction in the size of the tumor is observed after cycle 2, a third and final cycle will be performed. Followed by radiation therapy twice daily for approximately 6-7 weeks.

Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Phase I/II Pilot Study of Induction Chemotherapy With Docetaxel in Combination With Cisplatin and 5-Fluorouracil (5-FU) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Brigham and Women's Hospital

Sanofi

Dana-Farber Cancer Institute

Infections

Papilloma

Virus Diseases

Carboplatin

Cetuximab

Panitumumab

Antineoplastic Agents, Immunological

Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.

docetaxel

Given intravenously on day 1 of each cycle

cisplatin

5-FU

IMRT

cetuximab

carboplatin

Robert Haddad, MD

In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.

OBJECTIVES:

Primary

To determine rate of local-regional control at 2 years

Secondary

To determine Progression Free Survival at 2 and 5 years

To determine Overall Survival at 2 and 5 years

To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years

Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study

A Phase II Study of Docetaxel/Cisplatin/5-Fluorouracil (TPF) Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Using a Modified Radiation Dose in Patients With Newly Diagnosed HPV Positive, Locally Advanced Squamous Cell Carcinoma of the Oropharynx

2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.

Medical Oncology

The study was terminated early due to weak accrual. AE data were not accessible for results reporting due to the designation of study completed at the institution conduction the study.

TPF Induction Chemotherapy Followed by Chemoradiotherapy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The study was terminated early due to weak accrual. Because of the designation of study completed at the institution conducting the study, data collected systematically on the case report forms were not accessible for results reporting.

The study was terminated early due to weak accrual. Clinical outcome data were not accessible for results reporting due to the designation of study completed at the institution.

2-Year Local-Regional Control Rate

The analysis dataset is comprised of all treated patients. Since all patients have not been followed for survival for 5 years the 4-year rate is provided. All data provided was based on chart review and not from case report forms.

4-y Overall Survival Rate

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck	NCT00139269	Advanced Squamo... Squamous Cell C... SSCHN	Docetaxel Cisplatin 5-Fluorouracil	18 Years -	Dana-Farber Cancer Institute
Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study	NCT01221753	Squamous Cell C... Human Papilloma...	docetaxel cisplatin 5-FU IMRT cetuximab carboplatin	18 Years -	Dana-Farber Cancer Institute

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Spots Global Cancer Trial Database for sschn

Every month we try and update this database with for sschn cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sschn cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.