Know Cancer

or
forgot password

A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck


OBJECTIVES:

I. Determine the effect of thalidomide on survival of patients with recurrent or metastatic
squamous cell carcinoma of the head and neck.

II. Determine clinical response rates following this therapy in these patients. III.
Determine the toxic effects of thalidomide in these patients. IV. Determine the effect of
thalidomide on tumor angiogenesis in these patients.

OUTLINE:

Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in
individual patients on a weekly basis for the first 5 weeks. Treatment continues in the
absence of disease progression or unacceptable toxicity, or for 12 months past complete
response.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven squamous cell carcinoma of the head and neck

- Recurrent disease OR metastatic disease at initial diagnosis or at recurrence

- Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent
chemotherapy and radiotherapy allowed

- No more than one prior regimen of chemotherapy or biologic therapy for metastatic
disease

- Recurrence after adjuvant or induction chemotherapy may have received one additional
course of chemotherapy or biologic therapy

PATIENT CHARACTERISTICS:

- Age: 18 and over

- Performance status: Zubrod 0-2

- Life expectancy: At least 3 months

- WBC at least 3000/mm3

- Platelet count at least 100,000/mm3

- Hematocrit at least 30%

- Bilirubin no greater than 1.5 times normal

- SGOT/SGPT no greater than 1.5 times normal

- Creatinine no greater than 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile women must use 2 methods of effective contraception, 1 barrier and 1
hormonal, beginning at least 4 weeks before study and continuing during and for 1
month after study

- Men must use effective barrier contraception during and for 1 month after study

- No grade 2 or greater peripheral neuropathy

- No serious infection or other concurrent illness requiring immediate therapy

- Must be able to take oral medications

- No medical or social factors that would interfere with compliance

PRIOR CONCURRENT THERAPY:

- Any number of courses of one regimen of chemotherapy allowed

- No concurrent cytotoxic chemotherapy

- No concurrent radiotherapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Roy S. Herbst, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02299

NCT ID:

NCT00003850

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009