C-TPF in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT00402545|
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : November 1, 2009
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Drug: Cetuximab Drug: Docetaxel Drug: Cisplatin Drug: 5-Fluorouracil||Phase 1|
- After the screening tests confirm the participants eligibility, study treatment will begin.
- Prior to the start of study medication a port-a-cath will be inserted. This is done in the operating room and will require a separate consent form. During treatment a needle will be inserted into the port-a-cath through which the chemotherapy will be given. If the participant chooses not to have a port-a-cath, they will need to be hospitalized at Brigham and Women's Hospital to receive chemotherapy (approximately 5 days).
- Participants will receive three cycles of chemotherapy. Each cycle of treatment will last 21 days. On day 1 of each cycle, they will receive cetuximab intravenously for 2 hours, docetaxel (Taxotere) intravenously for 1 hour, cisplatin intravenously for 1 hour, and 5-FU over a period of 96 hours through an infusion pump. On days 8 and 15 of each cycle, participants will receive another dose of cetuximab intravenously for one hour.
- Not everyone who participates in this study will receive the same amount of 5-FU. A small group of participants will be given a certain dose of 5-FU through a continuous 4 day infusion. If they tolerate that well, the next group of people will receive a higher dose of 5-FU. This will continue until we can find the highest dose of the drug that can be given safely.
- Participants will be seen once a week in the clinic for a physical exam. At this time vital signs will be checked and participants will be asked general questions about their health and specific questions about any problems they might be experiencing. Blood tests will also be performed at this time.
- Within two weeks of completion of the third cycle of chemotherapy, participants will return to the clinic for evaluation. The following exams and procedures will be performed: Physical exam; blood tests; imaging of tumor (CT, MRI or PET); exam under anesthesia (EUA).
- Once the participant has completed all treatment, we would like to follow-up with them regarding the status of their cancer. Follow-up appointments will occur every 4-6 weeks for the first year, every 8-10 weeks up to the second year, every 3 months for the third year, and then every 6 months until the fifth year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Cetuximab/Docetaxel(Taxotere)/Cisplatin/5-Fluorouracil (C-TPF) in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
- Drug: Cetuximab
Given intravenously on days 1, 8 and 15 of each 21-day cycle for three cycles
- Drug: Docetaxel
Given intravenously on day 1 of each 21-day cycle for 3 cyclesOther Name: Taxotere
- Drug: Cisplatin
Intravenously on day 1 of each 21-day cycle for 3 cycles
- Drug: 5-Fluorouracil
Given by continuous infusion pump over a period of 96 hours(dosage wil vary depending upon when participant enrolls in trial)Other Name: 5-FU
- Determine the maximum tolerated dose (MTD) of Docetaxel/Cisplatin/5-Fluorouracil (TPF) induction chemotherapy when combined with cetuximab in an induction chemotherapy setting for locally advanced squamous cell cancer of the head and neck. [ Time Frame: 2 years ]
- To asses toxicity of this combination [ Time Frame: 2 years ]
- To determine the response rate in this patient population. [ Time Frame: 2 years ]
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): NCT00402545
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Robert I Haddad, MD||Dana-Farber Cancer Institute|