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Phase II Trial of Induction Therapy With Cetuximab (C225) and Carboplatin/Paclitaxel Chemotherapy in Previously Untreated Patients With Advanced (Stage IV) Head & Neck Squamous Cell Carcinoma

Phase 2
16 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

Phase II Trial of Induction Therapy With Cetuximab (C225) and Carboplatin/Paclitaxel Chemotherapy in Previously Untreated Patients With Advanced (Stage IV) Head & Neck Squamous Cell Carcinoma



- Determine the increase in clinical/radiographic complete response rate in patients with
previously untreated metastatic squamous cell carcinoma of the head and neck treated
with induction therapy comprising cetuximab, carboplatin, and paclitaxel.

- Determine the toxic effects of this regimen in these patients.


- Determine the pattern of tumor recurrence in patients treated with this regimen.

- Determine the quality of life of patients treated with this regimen.

- Determine the duration of response, time to progression, and survival of patients
treated with this regimen.

- Correlate effects of this regimen with biomarkers of response and predictors of
long-term outcome in these patients.

OUTLINE: This is a nonrandomized, open-label study.

Patients receive induction therapy comprising cetuximab IV over 1-2 hours, paclitaxel IV
over 1 hour, and carboplatin IV over 1 hour on day 1. Treatment repeats weekly for up to 6
courses in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks
later, patients undergo radiotherapy or chemoradiotherapy. Patients with T0, 1, 2 disease
undergo radiotherapy 5 days a week for 6 weeks. Patients with T3, 4 disease or unresectable
nodal disease undergo radiotherapy 5 days a week for 6 weeks and receive concurrent
cisplatin IV over 1-2 hours on days 1 and 22. Some patients may undergo primary surgical
resection before or instead of radiotherapy or chemoradiotherapy.

Quality of life is assessed at baseline and at 6, 12, and 24 months after completion of
radiotherapy or surgery.

After study completion, patients are followed every 3 months for 2 years, every 4 months for
1 year, and every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Inclusion Criteria:

1. Patients with histological proof (from the primary lesion and/or lymph nodes) of
squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or

2. Patients should have stage IV disease, stage T0-4 N2b/2c/3 M0 (for nasopharynx
patients, stage N1 disease is eligible). Measurable disease by Response Evaluation
Criteria in Solid Tumors (RECIST) is required.

3. Patients with stage Tx primary disease are eligible if there is N2b/3 adenopathy.

4. Karnofsky performance status of >/= 80 or Eastern Cooperative Oncology Group (ECOG)
point scale 0-1

5. Age > 16 years

6. Patients should have adequate bone marrow function defined as an absolute peripheral
granulocyte count (AGC) of > 1500 cells/mm3 and platelet count of > 100,000
cells/mm3; adequate hepatic function with bilirubin aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT)
may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal.
Alkaline phosphatase may be up to 4* ULN if SGPT and SGOT are normal. Patients who
have both SGPT and SGOT > 1.5 ULN and alkaline phosphatase > 2.5 * ULN are not
eligible. Normal PT/PTT and normal serum calcium (without intervention) are required.

7. Creatinine clearance > 40 ml/min determined by 24 hour collection or nomogram: CrCl
male = (140 - age) times (weight in kg)/serum Cr times 72 CrCl female = 0.85 times
(CrCl male)

8. Patients should have no serious acute or chronic co-morbid condition, or acute

9. Patients must sign a study-specific informed consent form.

Exclusion Criteria:

1. Histology other than squamous cell carcinoma.

2. Evidence of distant metastases (below the clavicle) by clinical or radiographic

3. Karnofsky performance status < 80 or ECOG>1

4. Prior chemotherapy, within the previous 3 years.

5. Prior radiotherapy to the head and neck.

6. Prior cetuximab therapy, prior therapy with any other drug that targets the EGFR
pathway, or prior therapy with a murine or chimeric monoclonal antibody.

7. Initial surgical resection rendering the patient clinically and radiologically
disease free.

8. Simultaneous primary invasive cancers.

9. Patients with another malignancy (excluding non melanoma skin cancers, and cancers
treated > 3 years prior for which patient remains continuously disease free).

10. Women of childbearing potential (WOCBP) who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period and for up to 4
weeks after the study. Subjects who are men must also agree to use effective
contraception. WOCBP must have a negative serum or urine pregnancy test (minimum
sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within
72 hours prior to the start of study medication.

11. WOCBP using a prohibited contraceptive method.

12. Women who are pregnant or breastfeeding.

13. Women with a positive pregnancy test on enrollment or prior to study drug

14. Refusal to sign the informed consent.

15. Pre-existing peripheral neuropathy Common Terminology Criteria for Adverse Events
(CTCAE) grade 2 or worse.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Complete Response

Outcome Description:

Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.

Outcome Time Frame:

Study period of 3 Years

Safety Issue:


Principal Investigator

Merrill S. Kies, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

September 2011

Related Keywords:

  • Head and Neck Cancer
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030