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Phase I/II Study of Escalating Doses of Taxol Used Concurrently With Ethyol and Accelerated Hyperfractionated Radiotherapy in the Treatment of Stage III and IV Carcinoma of the Head and Neck


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Oral Complications

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Trial Information

Phase I/II Study of Escalating Doses of Taxol Used Concurrently With Ethyol and Accelerated Hyperfractionated Radiotherapy in the Treatment of Stage III and IV Carcinoma of the Head and Neck


OBJECTIVES:

- Determine the maximum tolerated dose of paclitaxel with amifostine and radiotherapy in
patients with stage III or IV head and neck cancer.

- Determine the toxic effects and complications of this regimen in terms of mucositis
reduction in these patients.

- Determine the complete response rate and progression-free survival of patients treated
with this regimen.

- Determine whether amifostine modulates the plasma pharmacokinetics of paclitaxel in
these patients.

OUTLINE: This is a dose-escalation study of paclitaxel with and without amifostine.

Patients receive paclitaxel IV on days 1, 8, 15, 29, 36, and 43 for a total of 3-6 doses.
Patients also undergo radiotherapy twice daily for 6 weeks, except for days when paclitaxel
is given.

Cohorts of 2-5 patients receive escalating doses of paclitaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 2-3 patients experience
dose-limiting toxicity. An additional 10 patients are treated at the MTD.

After determination of the MTD for paclitaxel, subsequent patients also receive amifostine
IV over 15 minutes on days 1, 8, 29, and 36 and radiotherapy on days 2-5 and 30-33.
Determination of the MTD for this drug combination is carried out as with paclitaxel alone.

At 4 to 8 weeks after the last treatment of radiotherapy, patients undergo CT scanning to
determine response. Patients with residual masses undergo neck dissection. Patients with
complete or partial response at the primary site are followed without surgery.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage III or IV squamous cell head and neck cancer

- T3-4, N0-3, M0

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance Status:

- ECOG 0-2

Life Expectancy:

- Not specified

Hematopoietic:

- WBC at least 2,000/mm^3

- Platelet count at least 50,000/mm^3

Hepatic:

- Bilirubin no greater than 3.0 mg/dL

- SGOT no greater than 3 times upper limit of normal

Renal:

- Creatinine no greater than 3.0 mg/dL

Other:

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No concurrent beta-adrenergic blocking agents

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety

Outcome Description:

Safety is evaluated in this dose-escalation study

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Philip C. Amrein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000066028

NCT ID:

NCT00003193

Start Date:

January 1998

Completion Date:

September 2005

Related Keywords:

  • Head and Neck Cancer
  • Oral Complications
  • oral complications
  • 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 nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • 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
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Head and Neck Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115