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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

Phase 1
18 Years
Not Enrolling
Head and Neck Neoplasms

Thank you

Trial Information

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

- After the screening tests confirm the participants eligibility, study treatment will

- 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

- 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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Robert I Haddad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

July 2009

Related Keywords:

  • Head and Neck Neoplasms
  • C-TPF
  • 5-FU
  • squamous cell carcinoma of the head and neck
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115