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Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy 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 Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy Clinical research trials and Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy 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 Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy. Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy 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 Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy clinical trial. Human subjects often get the best healthcare available for their Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy 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 > "S" Clinical Trials Conditions > Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy  Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy
Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy
For Condition: Non-small cell lung cancer
Status: Recruiting
Sponsor(s): Genentech ,
Synopsis: The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced lung cancer that has recurred following prior chemotherapy.
Details:
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 - Signed informed consent - Tumor accessible to biopsy and willingness to undergo tumor biopsy - Age >= 18 years - Recurrent, histologically documented NSCLC, i.e., squamous cell, adeno-, or large cell anaplastic carcinoma. A cytologic diagnosis is acceptable (i.e. fine-needle aspiration or pleural fluid cytology). - Measurable disease with at least one lesion that can be accurately measured in at least one dimension (bilateral dimensions should be recorded). Each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain X-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. - Progression of disease during, or after completion of, at least one prior chemotherapy regimen, which should have contained either a platinum, a taxane or a vinca alkaloid (e.g. vinorelbine). There is no upper limit on the number of prior chemotherapy regimens each subject may have received. - Recovery from reversible acute effects of prior chemotherapy regimens or radiotherapy to NCI-CTC Grade <= 1 (excluding alopecia) - ECOG performance status of 0 or 1 - Use of an effective means of contraception for men, or for women of childbearing potential - Absolute neutrophil count >= 1500/mL, platelet count of >= 75,000/mL and hemoglobin >= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoietin [Aranesp] is permitted) - Serum bilirubin <= 1.5 x the upper limit of normal (ULN) and alkaline phosphatase, AST, and ALT <= 2.5 x ULN (ALT, AST, and alkaline phosphatase <= 5 x ULN for subjects with liver metastases) - Serum creatinine <= 1.5 x ULN - Internalized normalized ratio (INR) < 1.5 and activated partial thromboplastin time (aPTT) < 1.5 ULN (except for subjects receiving warfarin) Exclusion Criteria - Prior treatment with any HER pathway inhibitors (e.g., Herceptin [Trastuzumab], Iressa [gefitinib], Tarceva [erlotinib hydrochloride], C225, CI1033, TAK165 - Treatment with other experimental anti-cancer agents within 4 weeks prior to Day 1 - Histologically documented bronchioalveolar carcinoma - History or clinical or radiographic evidence of central nervous system or brain metastases - Ejection fraction, determined by ECHO, <50% - Uncontrolled hypercalcemia (> 11.5 mg/dL) - Prior exposure of > 360 mg/m2 doxorubicin or liposomal doxorubicin, > 120 mg/m2 mitoxantrone, or > 90 mg/m2 idarubicin - Ongoing corticosteroid treatment, except for subjects who are on stable doses of < 20 mg of prednisone daily (or equivalent), or for subjects who are taking corticosteroids for non-malignant conditions - History of other malignancies within 5 years of Day 1 except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or basal or squamous cell skin cancer - History of serious systemic disease, uncontrolled hypertension (diastolic blood pressure > 100 mmHg on two consecutive occasions), unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, or controlled hypertension are eligible) - Ongoing liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis - Active infection requiring IV antibiotics - Known human immunodeficiency virus infection - Pregnancy or lactation - Major surgery or significant traumatic injury within 3 weeks prior to Day 1, with the exception of tumor biopsy for the purposes of the study - Inability to comply with study and follow-up procedures - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
Total Enrollment: 60
Location and Contact Information:
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Corinne Turrell 916-734-3089
Cedars-Sinai Comprehensive Cancer Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Jewanna Moore 310-423-2133
Arizona Cancer Center *Recruiting*
Tucson, Arizona, 85724-5024
United States
Recruiting Jan Cohen 520-626-3434
Vanderbilt Ingram Cancer Center *Recruiting*
Nashville, Tennessee, 37232-5536
United States
Recruiting Thao Dang 800-811-8480
Arizona Cancer Center *Recruiting*
Scottsdale, Arizona, 85258
United States
Recruiting Molly Farmer 480-657-1354
Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Joan Lucca 617-632-5403
University of Texas MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Cathy Henceroth 713-745-1028
Memorial-Sloan Kettering Cancer Center *Recruiting*
New York City, New York, 10021-6007
United States
Recruiting Vincent Miller 212-610-0590
Additional Information:
Study ID Numbers: TOC2572g;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063154
Other Non-Small Cell Lung Cancer Studies:
1. Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
2. Phase II Study of Taxotere in Combination with Exisulind in Non-Small Cell Lung Cancer (NSCLC) Patients
3. INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer
4. INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
5. Evaluation of efficacy, safety and tolerability of Targretin capsules in patients with advanced or metastatic non-small cell lung cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
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Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy
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