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ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin Clinical research trials and ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin. ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin clinical trial. Human subjects often get the best healthcare available for their ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "Z" Clinical Trials Conditions > ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin  ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
For Condition: Skin Cancer
Status: Not yet recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: Patients will receive 250 mg ZD1839 daily by mouth (1 course = 4 weeks). Patients will receive 6 courses of treatment. A patient may continue to receive treatment on this study if he or she has stable disease or response.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion: - Provision of written informed consent. - Pathologically confirmed locoregional recurrence and/or metastatic SCC of the skin not amenable to curative therapy (i.e., surgery or radiation). - Evaluable, measurable disease. - ECOG performance status 0-2. - Adequate hematologic function as defined by an absolute neutrophil count >= 1,500/mm3, a platelet count >= 100,000/mm3, a WBC >= 3,000/ mm3, and a hemoglobin level of >= 9 g/dl. - Up to one prior chemotherapy regimen. - At least a 2-week recovery from prior therapy toxicity. - Age 18 years or older. - Disease free from a previously treated malignancy, other than the disease under study, for greater than 3 years. Patients with a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix, completely resected breast cancer will not be excluded. Exclusion: - Prior ZD1839 or other EGFR inhibiting agents. - Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ. - Any unresolved chronic toxicity greater then CTC grade 2 from previous anticancer therapy. - Incomplete healing from previous oncologic or other major surgery. - Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's Wort. Patients taking anticoagulants must have coagulation parameters followed (i.e., PT or PTT). - Absolute neutrophil counts less than 1500 x 109/liter (L) or platelets less than 100,000x 109/liter (L). - Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR). - In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease). - Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases. - Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. - Pregnancy or breast feeding (women of child-bearing potential) - The patient has uncontrolled seizure disorder, active neurological disease. - The patient has received any investigational agent(s) within 30 days of study entry.
Total Enrollment: 40
Location and Contact Information:
Additional Information:
Study ID Numbers: ID02-282;
Study Start Date: February 2004
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054691
Other Skin Cancer Studies:
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2. Study of Talabostat and Cisplatin in Advanced Melanoma
3. High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
4. Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome
5. ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
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ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
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