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

NCT ID: NCT00003850

Last Updated: 2013-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30

Brief 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.

Detailed 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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

thalidomide

Intervention Type: DRUG

Interventions

thalidomide

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy S. Herbst, MD, PhD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-ID-98270

Identifier Type: -

Identifier Source: secondary_id

NCI-T98-0074

Identifier Type: -

Identifier Source: secondary_id

CDR0000067011

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02299

Identifier Type: -

Identifier Source: org_study_id