NCT00003850

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
1 year until next milestone

First Posted

Study publicly available on registry

June 3, 2004

Completed
Last Updated

February 8, 2013

Status Verified

January 1, 2001

Enrollment Period

4.2 years

First QC Date

November 1, 1999

Last Update Submit

February 7, 2013

Conditions

Head and Neck Cancer

Keywords

recurrent metastatic squamous neck cancer with occult primarymetastatic squamous neck cancer with occult primary squamous cell carcinomastage IV squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: thalidomide

Interventions

thalidomideDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Roy S. Herbst, MD, PhD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 3, 2004

Study Start

April 1, 1999

Primary Completion

June 1, 2003

Last Updated

February 8, 2013

Record last verified: 2001-01

Locations

US(1)