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Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer Clinical research trials and Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer. Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer  Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer
Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer
For Condition: extensive stage small cell lung cancer,childhood thorax/respiratory cancer,Recurrent Small Cell Lung Cancer
Status: No longer recruiting
Sponsor(s): Norris Cotton Cancer Center ,
Synopsis: Patient Abstract available in the near future.
Details: OBJECTIVES: I. Determine the dose, safety, and antitumor response rate of lepirudin in patients with recurrent or extensive stage small cell lung cancer previously treated with chemotherapy. PROTOCOL OUTLINE: This is a dose escalation (in individual patients) study. Patients receive dose escalated lepirudin subcutaneously once or twice a day for 3-4 days. Dose escalation continues in each patient until aPTT prolongation occurs or the maximum dose level is reached. The patient then continues treatment on the maximum tolerated dose. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Pathologically confirmed recurrent or extensive stage small cell lung cancer; Received at least one prior chemotherapy regimen - Measurable or evaluable disease that has not been irradiated - No pleural effusions, bone metastases, brain metastases, elevated serum enzymes, or radionuclide scans as the sole indicator lesion - Brain metastases allowed if patients received cranial irradiation and have no clinical evidence of brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 3 weeks since prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy - Surgery: At least 6 weeks since major surgery, trauma, or needle biopsy of any organ - Other: No concurrent anticoagulant or platelet inhibitor therapy --Patient Characteristics-- - Age: Not specified - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL; PT and aPTT normal - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min - Cardiovascular: No unstable heart rhythm; No unstable angina; No clinical evidence of congestive heart failure; No prior cerebrovascular accident or stroke; No uncontrolled or severe hypertension - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; At least 6 weeks since any signs or symptoms of bleeding; No history of bleeding disorder; No bacterial endocarditis or other active infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesRigas, Study Chair, Norris Cotton Cancer Center
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
Additional Information:
Study ID Numbers: CDR0000066838; DMS-9815,NCI-V98-1512
Study Start Date: November 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003726
Other Extensive Stage Small Cell Lung Cancer Studies:
1. Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer
2. Chloroquinoxaline Sulfonamide in Treating Patients With Small Cell Lung Cancer
3. Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
4. Combination Chemotherapy Plus Augmerosen in Treating Patients With Untreated Extensive-Stage Small Cell Lung Cancer
5. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Related Studies:
Other extensive stage small cell lung cancer Clinical Trials
Other New Hampshire Clinical Trials
Other Lebanon Clinical Trials
Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer
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