Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003850
• Other study ID #: NCI-2012-02299
• Secondary ID: MDA-ID-98270NCI-
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 7, 2013
• Start date: April 1999

Study information

• Verified date: January 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase II trial to study the effectiveness of thalidomide in treating patients with recurrent or metastatic head and neck cancer. Thalidomide may stop the growth of head and neck cancer by stopping blood flow to the tumor.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• thalidomide

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,