|
Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma Clinical research trials and Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma. Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma  Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
For Condition: Non-Small-Cell Lung Carcinoma
Status: Recruiting
Sponsor(s): ILEX Products ,
Synopsis: This is a Phase II, non-randomized, open label study of ILX651 in patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate. The secondary objectives are to determine the progression free survival, duration of response, time to tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic profile.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: (1) Histologically confirmed locally advanced or metastatic NSCLC previously treated with 2 prior chemotherapy regimens (not including prior adjuvant therapy for stage I or II disease). (2) Disease recurrence or progression after prior therapy with a platinum-based and a taxane-based regimen, given either concurrently or separately. (3) Measurable disease. Measurable lesions should be outside the field of radiation. Where measurable lesions are within a previously irradiated field, there must be objective evidence of progression of the lesion prior to patient enrollment. (4) Male or female patients greater than or equal to 18 years of age. (5) ECOG performance status of 0 or 1. (6) Must have adequate organ and immune system function as indicated by the following laboratory values, obtained less than or equal to 2 weeks prior to registration: - Absolute neutrophil count (ANC) greater than or equal to 1.5 x 1,000,000,000 - Hemoglobin greater than or equal to 9.0 g/dL - Platelet count greater than or equal to 100 x 1,000,000,000/L - Serum creatinine or calculated creatinine clearance less than or equal to 1.5 mg/dL or greater than or equal to 60 mL/min - Serum total bilirubin within limits of normal values - AST and ALT less than or equal to 2 times the upper limit of normal (ULN) - Alkaline phosphatase within limits of normal values (7) Anti-cancer therapy, major surgery, or irradiation must have been completed at least 3 weeks before enrollment in this study. Patient must have recovered from the acute side effects incurred as a result of previous therapy. (8) Female patients with childbearing potential must have a negative pregnancy test within 7 days of study enrollment. Men and women of reproductive potential must use an effective contraceptive method while enrolled in the study. (9) Signed informed consent (includes HIPAA authorization). Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study admission: (1) Patients with uncontrolled congestive heart failure or angina, patients with a history of myocardial infarction within 2 months of enrollment, or patients with cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification. (2) Previously treated with > 2 prior chemotherapy regimens for advanced or metastatic disease. (3) Prior radiotherapy to the only site of measurable disease. (4) Known hypersensitivity to study drug or its analogs. (5) Use of investigational agents within previous 30 days. (6) Known, active infection, or known HIV positive or presence of an AIDS related illness. (7) Active secondary malignancy except minor skin cancers. (8) Presence of symptomatic active brain metastases, including leptomeningeal involvement. (9) Any significant concurrent disease or illness, or psychiatric disorders or alcohol or chemical abuse that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results. (10) Pregnant or lactating females.
Total Enrollment: 60
Location and Contact Information:
Joe Arrington Cancer Center *Recruiting*
Lubbock, Texas, 79410
United States
Recruiting Dawn Howerton 806-725-7994
US Oncology / Central Indiana Cancer Centers *Recruiting*
Indianapolis, Indiana, 46227
United States
Recruiting Cindy Elkins 317-859-5500
US Oncology / Texas Cancer Center *Recruiting*
Dallas, Texas, 75230
United States
Recruiting Cindi Bedel 972-867-3577
Cancer Institute Medical Group *Recruiting*
Santa Monica, California, 90404
United States
Recruiting Pat Ames 310-582-7974
US Oncology/ Arizona Clinical Research Center *Recruiting*
Tucson, Arizona, 85712
United States
Recruiting Sue Logsdono 520-290-2510
Sarah Cannon Cancer Center *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Joan Erland 615-986-4300
Anshutz Cancer Pavillion *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Lynn McGree 720-848-0676
Hematology and Oncology Specialists *Recruiting*
New Orleans, Louisiana, 70115
United States
Recruiting Mary Ostroske 504-894-7115
US Oncology / Ocala Oncology *Recruiting*
Ocala, Florida, 34474
United States
Recruiting Renee Genther 317-859-4310
US Oncology / Tyler Cancer Center *Recruiting*
Tyler, Texas, 75702
United States
Recruiting Linda Dunklin 903-579-9800
Additional Information:
Study ID Numbers: ILX651-231;
Study Start Date: December 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078455
Other Non-Small-Cell Lung Carcinoma Studies:
1. Alimta (pemetrexed) in Patients with Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy
2. Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion in Patients with Pulmonary and Pleural Malignancies
3. Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Non-Small Cell Lung Cancer
4. p53 Peptide Vaccination to Treat Lung Cancer
5. Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
Related Studies:
Other Non-Small-Cell Lung Carcinoma Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
|
|
|
|
|
|
|
|
