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Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck

Phase 2
21 Years
Open (Enrolling)
Head and Neck Cancer

Thank you

Trial Information

Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck


- Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with
concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of
high-risk stage III or IV squamous cell carcinoma of the head and neck.

- Determine the disease-free and overall survival of patients treated with this regimen.

- Determine the acute and chronic toxicity of this regimen in these patients.

- Determine the patterns of failure in patients treated with this regimen.

OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical
resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on
approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5
weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3
hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.

Inclusion Criteria


- Histologically proven stage III or IV squamous cell carcinoma of the oral cavity,
oropharynx, larynx, or hypopharynx

- Gross total resection completed or planned

- No less than gross total resection

- No disease requiring staging surgery

- Prior gross total resection completed with one or more of the following risk factors:

- Histologically proven multiple lymph node metastases

- At least 1 lymph node with extracapsular extension of tumor

- Positive margin(s) of resection, including mucosal margins and/or soft tissue or
deep margins of resection OR

- Gross total resection planned within 14 days of study enrollment with anticipated
need for postoperative radiotherapy for one of the following:

- Multiple clinically/radiologically evident lymph nodes of at least 1.5 cm

- Single clinically/radiologically evident lymph node of at least 3 cm

- Histologically proven lymph node metastases

- No T3, N0 glottic cancer

- No nasopharyngeal or paranasal sinus carcinoma

- No distant metastases



- 21 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST or ALT no greater than 1.5 times ULN


- Creatinine no greater than 1.5 ULN


- No unstable angina

- No myocardial infarction within the past 6 months unless successfully treated with
coronary artery bypass graft or percutaneous transluminal coronary angioplasty

- No uncontrolled arrhythmia

- No second or third degree heart block or other clinically significant conduction
system abnormality unless pacemaker is in place


- No severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations
within the past year


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No pre-existing grade 2 or greater peripheral neurotoxicity

- No other prior malignancy within the past 3 years except low-risk nonmelanomatous
skin cancer; carcinoma in situ (e.g., breast, cervix, or bladder); or stage T1-2, low
to moderate grade prostate cancer

- No significant wound infection

- No fistula

- No major wound dehiscence

- Nutritional status adequate


Biologic therapy:

- Concurrent colony-stimulating factors for neutropenic fever during study
chemoradiotherapy allowed


- No prior chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- No prior radiotherapy to head and neck


- See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Randal S. Weber, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • Head and Neck Neoplasms



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