ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn if the drug ZD1839 (Iressa) can shrink or slow the growth of cancer in participants with recurrent and/or metastatic squamous cell cancer (SCC) of the skin. The safety of this drug will also be studied.

Clinical Trial Description

ZD1839 is a new drug that may slow or stop cell growth in humans.

Epidermal growth factor receptor (EGFR) may be involved in certain types of cancer, including squamous cell carcinoma of the skin. When EGFR is stimulated, a series of chemical reactions starts that results in a tumor being "told" to grow. ZD1839 tries to stop these reactions by blocking EGFR. This may stop tumors from growing.

In this study, participants will take ZD1839 by mouth daily. Once the treatment has started, participants will return to the clinic before every treatment cycle (every 4 weeks) for the first 4 months then every 8 weeks thereafter. At these visits, participants will have a physical exam and blood tests will be performed. About 2-4 teaspoons of blood will be drawn at each visit. The doctor will also check on how participants are tolerating ZD1839 (side effects). Every 8 weeks, participants will have their tumor evaluated by radiographic scans. This may include either a CT or MRI and a chest X-ray.

During treatment, participants should not take any other medication, including non-prescription drugs such as aspirin or herbal products without the approval of their doctor.

Participants will continue taking the trial drug until the tumor grows, a severe side effect occurs, they withdraw consent, or the study is closed. The study will be closed 12 months after the last participant is enrolled.

This is an investigational study. The FDA has approved ZD1839 for the treatment of advanced lung cancer, but the FDA has authorized ZD1839 for research only in the treatment of skin cancer. About 40 participants will take part in this study. All will be enrolled at M.D. Anderson. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00054691
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	May 2004
Completion date	October 2012

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02721459` - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma	Phase 1
Completed	`NCT03740815` - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection	N/A
Recruiting	`NCT05779423` - Cryoablation+Ipilimumab+Nivolumab in Melanoma	Phase 2
Terminated	`NCT01468818` - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma	Phase 2
Completed	`NCT01820234` - Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event	N/A
Completed	`NCT00535769` - Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use	Phase 0
Completed	`NCT00526032` - Melanoma Detection by Oblique-Incidence Optical Spectroscopy	N/A
Completed	`NCT00588341` - Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection	Phase 2
Active, not recruiting	`NCT01447199` - The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)
Enrolling by invitation	`NCT04758988` - AI Augmented Training for Skin Specialists	N/A
Not yet recruiting	`NCT04534868` - Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area	N/A
Recruiting	`NCT04138342` - Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer	Phase 1
Completed	`NCT03673917` - Cosmetology Students and Skin Cancer	N/A
Recruiting	`NCT04341064` - Sun-safe Habits Intervention and Education	Phase 3
Completed	`NCT04206995` - Cancer Sensing: Evaluation of Odour Sampling Techniques
Recruiting	`NCT05574101` - A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer	Phase 2
Not yet recruiting	`NCT05860881` - Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)	Phase 3
Completed	`NCT05146622` - Virtual Sun Safe Workplaces Ph I
Recruiting	`NCT05068310` - Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
Recruiting	`NCT03889899` - Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms