|
Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer 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 Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer Clinical research trials and Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer 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 Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer. Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer 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 Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer 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 Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer  Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer
Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer
For Condition: Carcinoma, Non-Small-Cell Lung
Status: No longer recruiting
Sponsor(s): ImClone Systems , University of Colorado,Greenwich Hospital,Indiana University - Purdue University Indianapolis
Synopsis: The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for efficacy and safety throughout the duration of the study.
Details: The study will enroll approximately 33 chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive 3-week cycles of therapy with the exception of the initial cycle where the patients will receive 4 cycles of therapy. Patients will be enrolled after EGFr expression is confirmed and the study inclusion and exclusion criteria are met. An initial dose of cetuximab will be administered prior to the initiation of chemotherapy. Thereafter, cetuximab will be infused weekly. On the first day of each cycle, a paclitaxel infusion will be administered post completion of the cetuximab infusion, immediately followed by a carboplatin infusion. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for a tumor response at the end of every two cycles of therapy and evaluated for safety throughout the study.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: The following inclusion criteria must be met: - The patient has stage IV NSCLC with either present or prior histologic or pathologic confirmation of NSCLC - The patient has uni-dimensionally measurable stage IV NSCLC - The patient has chemotherapy-naive stage IV NSCLC. The patient may have recurrent disease if prior radiation therapy was received. Pathological confirmation of recurrence is required for disease within a radiation portal. - The patient's ECOG performance status is 2 at study entry. - The patient has immunohistochemical evidence of EGFr expression (1+). Patients who do not have tumor tissue available for EGFr testing will undergo a biopsy of an accessible tumor. EGFr expression must be confirmed prior to study entry. - The patient has given signed informed consent. - The patient is 18 years of age or older. - The patient has adequate hematologic function, as defined by an absolute neutrophil (ANC) 1,500/mL3 , a WBC count3,000/mL3, a platelet count 100,000/mL3, and a hemoglobin level 9g/dL. - The patient has adequate hepatic function as defined by a total bilirubin level 1.5 X the upper limit of normal (ULN) and an alkaline phosphatase, AST, and ALT level 2.5 X the ULN. - The patient has adequate renal function with a serum creatinine level 1.5 mg/dL or a creatinine clearance 60 cc/minute. - The patient is 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 preinvasive carcinoma of the cervix will not be excluded). - The patient, if a woman, agrees to use effective contraception if childbearing potential exists. The patient, if a man, agrees to use effective contraception. Exclusion Criteria: The following ten exclusion criteria are for this study: - The patient has received prior cetuximab therapy. - The patient has disease amenable to curative surgery. - The patient has received prior chemotherapy for the disease under study. - The patient has received wide field radiation therapy within 4 weeks prior to the first infusion of cetuximab. The patient may have local irradiation for the management of tumor-related symptoms. - The patient has undergone major thoracic or abdominal surgery within 30 days (to allow for a full recovery)prior to the first infusion of cetuximab. - The patient has a history of uncontrolled angina,arrhythmias, or congestive heart failure. - The patient has uncontrolled seizure disorder, active neurological disease (not tumor related), or grade 2 neuropathy (patients with meningeal or central nervous system [CNS] involvement by the tumor will be eligible). - The patient has a history of hypersensitivity to Cremophor EL. - The patient, if a woman, is pregnant (confirmed by serum BHCG) or breastfeeding. - The patient has received any investigation agents within 30 days of study entry.
Total Enrollment: 33
Location and Contact Information:
IUPUI
Indianapolis, Indiana, 46202
United States
University of Colorado
Denver, Colorado, 80262
United States
Greenwich Hospital
Greenwich, Connecticut, 06830
United States
Additional Information:
Study ID Numbers: CP02-9932;
Study Start Date: December 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034541
Other Carcinoma, Non-Small-Cell Lung Studies:
1. Comparative Trial of Pivanex and Docetaxel vs Docetaxel Monotherapy in Patients with Advanced Non-Small Cell Lung Cancer
2. A Phase II Study of Epothilone Analog BMS-247550 in Patients with non-Small Cell Lung Cancer Who Have Failed First Line Platinum Based Chemotherapy
3. OSI-774 (Tarceva) in Treating Patients with Stage III or Stage IV Non-Small Cell Lung Cancer
4. CPG 7909 Injection in non-small cell lung cancer
5. Study of the Efficacy of an Investigational Drug in Adult Patients with Non Small-Cell Lung Cancer (NSCLC)
Related Studies:
Other Carcinoma, Non-Small-Cell Lung Clinical Trials
Other Connecticut Clinical Trials
Other Greenwich Clinical Trials
Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer
|
|
|
|
|
|
|
|
