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C-TPF in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00402545
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : November 1, 2009
Brigham and Women's Hospital
Bristol-Myers Squibb
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
The purpose of this research study is to determine the safest and most effective dose of 5-FU that can be given with docetaxel (Taxotere), Cisplatin and cetuximab to patients with newly diagnosed locally advanced squamous cell carcinoma of the head and neck. We will also be studying the toxicity of this regimen of 4 drugs and the tumor response.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Cetuximab Drug: Docetaxel Drug: Cisplatin Drug: 5-Fluorouracil Phase 1

Detailed Description:
  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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 cycles
    Other 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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To asses toxicity of this combination [ Time Frame: 2 years ]
  2. To determine the response rate in this patient population. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically proven squamous cell carcinoma of the head and neck.
  • Primary tumor sites eligible: oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx. Unknown primary SCC will also be eligible.
  • Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound or CAT scan.
  • At lease one uni- or bi-dimensionally measurable lesion by RECIST criteria.
  • 18 years of age or older
  • ECOG performance status of 0-1
  • Adequate bone marrow, hepatic and renal functions as outlined in the protocol.

Exclusion Criteria:

  • Pregnant or breast feeding women
  • Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
  • Symptomatic peripheral neuropathy greater or equal to grade 2
  • Symptomatic altered hearing > grade 2 by CIT-CTC criteria
  • Unstable cardiac disease despite treatment, myocardial infarction within 6 months
  • History of significant neurologic or psychiatric disorders including dementia or seizures
  • Active clinically significant uncontrolled infection
  • Active peptic ulcer disease defined as unhealed or clinically active
  • Hypercalcemia
  • Active drug addiction, including alcohol, cocaine or intravenous drugs use
  • Chronic Obstructive Pulmonary Disease
  • Autoimmune disease requiring therapy, prior organ transplant, or HIV infection
  • Interstitial lung disease
  • Involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry
  • Concurrent treatment with any other cancer drug
  • Prior EGFR therapy
  • Prior severe infusion reaction to antibody therapy
  • Participation in an investigational trial within 30 days of study entry

Information from the National Library of Medicine

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 identifier (NCT number): NCT00402545

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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Bristol-Myers Squibb
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Principal Investigator: Robert I Haddad, MD Dana-Farber Cancer Institute
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Responsible Party: Robert Haddad, MD, Dana-Farber Cancer Institute Identifier: NCT00402545    
Other Study ID Numbers: 06-128
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: November 1, 2009
Last Verified: October 2009
Keywords provided by Dana-Farber Cancer Institute:
squamous cell carcinoma of the head and neck
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological