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A Phase I/II Trial of Abraxane in Combination With Carboplatin, Erbitux and Intensity Modulated Radiation Therapy (IMRT)for Treatment of Locally Advanced Squamous Cancer of the Head and Neck

Phase 1/Phase 2
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck, Basaloid Squamous Cell Carcinoma, Undifferentiated Carcinoma, Adenosquamous Cell Carcinoma

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Trial Information

A Phase I/II Trial of Abraxane in Combination With Carboplatin, Erbitux and Intensity Modulated Radiation Therapy (IMRT)for Treatment of Locally Advanced Squamous Cancer of the Head and Neck

- Participants will receive radiation therapy, typically done Monday through Friday for
about seven weeks (participants will sign a separate consent form with the radiation
oncologist that will outline what to expect from this treatment).

- On the first week of the study (in the week prior to the start of radiation)
participants will receive one dose of Erbitux only. After that, they will receive all
three drugs (Erbitux, Abraxane and Carboplatin) weekly during the 7 weeks of radiation.
These drugs are given intravenously. Each participant will receive the same dose of
Erbitux and carboplatin. The dose of Abraxane will depend upon when the participant is
enrolled in the study and if the maximum tolerated dose has been established.

- Participants will be examined every week during the treatment. A physical exam will be
performed along with questions about general health and specific questions about any
problems the participant is experiencing.

- Blood tests will be done every week during treatment and include chemistry and
hematology tests.

- Participants will be asked to return to the clinic within 8 to 10 weeks of finishing
the treatment. The following exams and procedures will be performed during this time:
physical exam; blood tests; imaging of the tumor; imaging of the chest and; neck
surgery (if the study doctors think that the participant may benefit from surgery to
remove lymph nodes in the neck).

Inclusion Criteria:

- Histologically or cytologically proven squamous cell carcinoma of th head and neck or
its variants. Primary tumor sites eligible include nasopharynx, oral cavity,
oropharynx, hypopharynx, larynx, or unknown primary SSCHN. Although they have
squamous histology, tumors of the skin, nasal cavity and paranasal sinuses are
excluded because their responsiveness to chemotherapy and radiotherapy may differ.

- Stage III or IV disease, without evidence of distant metastasis, according to the
American Joint Committee on Cancer.

- Measurable disease, according to RECIST.

- Treatment-naive SSCHN, i.e. no prior chemotherapy, radiotherapy or attempted complete

- < CTCAE v3.0 Grade 2 neuropathy

- 18 years of age or older

- ECOG Performance Status of 0 or 1

- No active alcohol addiction or other condition that, in the opinion of the study
investigators, would interfere with the subject's ability to comply with the
treatment plan.

- Lab values as outlined in the protocol

- Negative pregnancy test within 7 days of study entry

Exclusion Criteria:

- Pregnant or breast-feeding women, or women and men of childbearing potential not
willing to use adequate contraception while receiving treatment and for at least 6
months thereafter.

- Symptomatic peripheral neuropathy Grade 2 or greater by CTCAE v3.0

- History of other malignancy within the previous 5 years, except for non-melanoma skin
cancer, carcinoma in situ of the cervix, bladder or head and neck.

- Prior therapeutic radiation to the head and neck

- Other serious illness or medical conditions, including but not limited to: unstable
cardiac disease or myocardial infarction within 6 months prior to study entry;
history of significant neurologic disorder, including advanced dementia or
uncontrolled seizure disorder; clinically significant uncontrolled infection; active
peptic ulcer disease defined as unhealed or clinically active ulcer; hypercalcemia;
active drug addiction including cocaine or intravenous drug use, defined as occuring
within 6 months preceding diagnosis; chronic obstructive pulmonary disease;
autoimmune disease requiring active therapy; severe psoriasis; chronic uncontrolled

- Patients who experienced involuntary weight loss of more than 20% of their body
weight in the two months preceding study entry

- Concurrent treatment with any other anticancer therapy

- Prior therapy that targets the EGFR pathway

- Participation in an investigational drug trial within 30 days of study entry

Type of Study:


Study Design:

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

Outcome Measure:

Phase I: To identify the maximally tolerated dose of Abraxane given with carboplatin and Erbitux plus concurrent IMRT.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Roy B. Tishler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

November 2007

Completion Date:

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Basaloid Squamous Cell Carcinoma
  • Undifferentiated Carcinoma
  • Adenosquamous Cell Carcinoma
  • Abraxane
  • IMRT
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Carcinoma, Adenosquamous