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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Bristol-Myers Squibb
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00402545
First received: November 21, 2006
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Head and Neck Neoplasms
Drug: Cetuximab
Drug: Docetaxel
Drug: Cisplatin
Drug: 5-Fluorouracil
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To asses toxicity of this combination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To determine the response rate in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: January 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402545

Locations
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
Investigators
Principal Investigator: Robert I Haddad, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Robert Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00402545     History of Changes
Other Study ID Numbers: 06-128, CA225249
Study First Received: November 21, 2006
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
SCCHN
C-TPF
5-FU
squamous cell carcinoma of the head and neck

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cetuximab
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 28, 2014