|
Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC) Clinical research trials and Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC) health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC). Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC) Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC) clinical trial. Test subjects typically receive the most expert healthcare available for their Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC) condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)  Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)
Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)
For Condition: Carcinoma, Non-Small-Cell Lung
Status: No longer recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: The primary objective of this Phase II study is to assess the safety, pharmacokinetics and effectiveness of ABT-510 in combination with standard carboplatin/paclitaxel chemotherapy in subjects with stage IIIb or IV NSCLC.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria A subject will be eligible for study participation if all of the following criteria are met: 1.The subject is at least 18 years of age. 2.The subject has histologically or cytology documented Stage IIIB with pleural effusion or Stage IV NSCLC. The subject must have measurable disease (RECIST Criteria for Tumor Response). 3.The subject has not received first line therapy for treatment of NSCLC. 4.The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy. 5.The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. 6.The subject is able to self-administer or has a caregiver who can reliably administer SC injections. 7.The subject must have adequate bone marrow, renal and hepatic function as follows: Bone marrow: White blood cell count (WBC) >= 3,000/mm3; Platelets; >= 100,000/mm3; Hemoglobin >= 9.0 g/dL; Renal function: Serum creatinine <= 2.0 mg/dL; Hepatic function: Bilirubin <= 1.5 mg/dL; AST and ALT <= 1.5 X the upper normal limit (ULN); unless liver metastases are present, then AST and ALT <= 5.0 x ULN. 8.The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures. Exclusion Criteria A subject will be ineligible for study participation if any of the following criteria are met: 1. The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases. 2. The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation for catheter prophylaxis will be permitted; PT/PTT must be within normal limits. 3. The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks from Study Day 1) or currently exhibits other clinically significant events of bleeding. 4. The subject has received investigational therapy within four weeks prior to study drug administration. 5. The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures. 6. The subject has previous or current malignancies at other sites, with the exception of: Adequately treated in situ carcinoma of the cervix uteri; Basal or squamous cell carcinoma of the skin; Previous nonpulmonary malignancy confined and surgically resected with no evidence of active malignancy.
Total Enrollment:
Location and Contact Information:
The West Cancer Clinic
Memphis, Tennessee, 38120
United States
University of Wisconsin
Madison, Wisconsin, 53792-5666
United States
University of Chicago
Chicago, Illinois, 60637-1470
United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Additional Information:
Study ID Numbers: M02-429;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061646
Other Carcinoma, Non-Small-Cell Lung Studies:
1. ALIMTA (pemetrexed) Plus Gemcitabine (Gemzar) for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer who have not had Previous Chemotherapy.
2. Vaccine Treatment for Advanced Non-Small Cell Lung Cancer
3. ZD6474 Alone or in Combination with Paclitaxel and Carboplatin in Subjects with Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
4. Mistletoe Extract and Gemcitabine for the Treatment of Solid Tumor Cancers
5. Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients with Stage III Non-Small Cell Lung Cancer
Related Studies:
Other Carcinoma, Non-Small-Cell Lung Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)
|
|
|
|
|
|
|
|
