|
ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) Clinical research trials and ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC). ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) clinical trial. Participants frequently get the best healthcare available for their ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)  ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
For Condition: Lung Cancer,Carcinoma, Non-Small-Cell Lung Neoplasm,Neoplasm Metastasis
Status: Recruiting
Sponsor(s): Immunex Corporation , Abgenix
Synopsis: Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in combination with paclitaxel and carboplatin in the treatment of advanced NSCLC.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - 18 years of age or older. - Female patients who are post-menopausal, surgically sterilized, or of childbearing potential using acceptable birth control and have a negative serum pregnancy test upon study entry; or male patients willing to use contraception upon study enrollment. - Diagnosis of NSCLC. - Bidimensionally measurable disease. - Tumor tissue available for immunohistochemistry studies. - Tumor over-expressing EGFR as ascertained by immunohistochemistry. - Disease stage IIIB with pericardial or pleural effusion, or stage IV. - Life expectancy of at least 12 weeks. - ANC greater than or equal to 1.5 x 109/L, platelet count greater than or equal to 100 x 109/L. - Creatinine clearance greater than 15 mL/min. - Alkaline phosphatase less than or equal to 3x ULN, AST less than or equal to 3 x ULN, ALT less than or equal to 3 x ULN, bilirubin less than or equal to 1.5 ULN. - ECOG score of less than 2. - Brain metastases, if present, must be controlled and asymptomatic. EXCLUSION CRITERIA: - Calcium greater than or equal to 11.6 mg/dL (treatment for hypercalcemia allowed). - Use of any investigational therapy within 30 days of ABX-EGF infusion. - Any cancer therapy for NSCLC other than radiation therapy, surgery, or steroids. - Radiation therapy within 2 weeks before ABX-EGF infusion. - LVEF less than 45% as measured by MUGA. - Symptomatic ventricular arrhythmia or symptomatic conduction abnormality. - Myocardial infarction within 1 year before first dose of study drug. - History of cancer that has required treatment or been active within past 5 years, other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ. - Known to be HIV positive. - Any patient who's best medical interests would not be met by entry in the study in the opinion of the Investigators.
Total Enrollment: 210
Location and Contact Information:
Research Site *Recruiting*
San Antonio, Texas,
United States
Recruiting
Additional Information:
Study ID Numbers: 054.0004;
Study Start Date: January 2002
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034346
Other Carcinoma, Non-Small-Cell Lung Neoplasm Studies:
1. A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer
2. Stem Cell Transplant for Advanced Renal Cell Cancer
3. Antimetabolite Induction, High-Dose Alkylating Agent Consolidation and Retroviral Transduction of the MDR1 Gene into Peripheral Blood Progenitor Cells Followed by Intensification Therapy with Sequential Paclitaxel and Doxorubicin for Stage 4 Breast Cancer
4. A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
5. A Phase I/II Trial of Vaccination with Mutant Ras Peptide Pulsed Dendritic Cells in the Treatment of HLA A2.1 Positive Patients with Colorectal Cancer
Related Studies:
Other Carcinoma, Non-Small-Cell Lung Neoplasm Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
|
|
|
|
|
|
|
|
