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Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer 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 Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer Clinical research trials and Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer 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 Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer. Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer 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 Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer 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.
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Home > "S" Clinical Trials Conditions > Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer  Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer
Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer
For Condition: Carcinoma, Non-Small-Cell Lung
Status: Recruiting
Sponsor(s): Novacea , Aventis Pharmaceuticals
Synopsis: This Phase 1/2 clinical trial is a multi-center, open-label study with two main objectives. The first is to determine the maximum-tolerated dose of DN-101 when administered in combination with Taxotere (docetaxel) every three weeks. The second is to evaluate the safety and objective tumor response rate of the combination in NSCLC. DN-101 doses will be escalated at three dosing levels. Patients will receive oral DN-101 on day one, followed by intravenous docetaxel on day two of a 21-day cycle. Treatment cycles will be repeated at the same dose level each 21 days until disease progression or unacceptable toxicity.
Details: DN-101 is an oral anti-cancer therapy for solid tumors and various hematologic malignancies. DN-101 is a unique formulation of calcitriol specifically designed for use in cancer. Calcitriol is a naturally occurring hormone and the most potent biologically active form of vitamin D. In high doses, calcitriol is active in many laboratory and animal models of cancer and synergistic with many commonly used chemotherapeutic agents. Until recently, the clinical use of calcitriol as an anti-cancer therapy was limited by hypercalcemia at doses required for anti-tumor activity. Based upon clinical results to date, Novacea believes it has successfully developed a solution to this problem through development of DN-101. Chemotherapy for NSCLC, while not curative, has been shown to prolong survival in patients with unresectable disease. A number of different chemotherapy agents have been shown to have single-agent activity in NSCLC. These include cisplatin, carboplatin, vinorelbine, gemcitabine, paclitaxel and docetaxel. For first-line therapy of Stage IIIB or Stage IV NSCLC, these agents are generally used in combination. In most cases, first-line chemotherapy consists of a platinum-based agent, either cisplatin or carboplatin, and another chemotherapeutic. Only one agent, Taxotere®, has been approved in the United States by the Food and Drug Administration for use as second-line chemotherapy in NSCLC.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Histopathologically or cytologically proven non-small cell carcinoma of the lung (NSCLC), either Stage IIIB or Stage IV, that has progressed on or after platinum-based chemotherapy - Measurable disease by RECIST criteria - Eastern Cooperative Oncology Group (ECOG) Performance Status < 1 - Life expectancy > 3 months - Age > 18 years - Agrees to use adequate contraception throughout the treatment period and for at least 6 months following treatment - Able to give informed patient consent
Total Enrollment: 62
Location and Contact Information:
Overall Study Official:
HowardWest, Study Chair, Swedish Cancer Institute
Hematology-Oncology Centers of the Northern Rockies *Recruiting*
Billings, Montana, 59101
United States
Recruiting Mary VanZandt 406-238-6962
Kaiser Permanente Medical Center (Northern California) *Recruiting*
Vallejo, California, 94589
United States
Recruiting Desiree Goldstein 707-651-2797
Yakima Regional Cancer Care Center *Recruiting*
Yakima, Washington, 98902
United States
Recruiting Beth Parker 509-225-2448
Rainer Oncology *Recruiting*
Puyallup, Washington, 98372
United States
Recruiting Melissa Gil 253-841-9357
Alta Bates Comprehensive Cancer Center *Recruiting*
Berkeley, California, 94704
United States
Recruiting Beth Davis 510-204-3428
Swedish Cancer Institute *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Toni Oien 206-386-2831
Kaiser Permanente Northwest *Recruiting*
Portland, Oregon, 97227
United States
Recruiting Marjorie Erwin 503-331-6294
Additional Information:
Study ID Numbers: DN101-004;
Study Start Date: June 2003
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066885
Other Carcinoma, Non-Small-Cell Lung Studies:
1. Temozolomide for Treatment of Brain Metastases from Non-Small Cell Lung Cancer
2. ZD6474 Alone or in Combination with Paclitaxel and Carboplatin in Subjects with Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
3. Non-small cell lung cancer refractory to platinum-based therapy
4. Utility of Anatometabolic Imaging for Radiation Treatment Planning for Lung Cancer
5. Comparative Trial of Pivanex and Docetaxel vs Docetaxel Monotherapy in Patients with Advanced Non-Small Cell Lung Cancer
Related Studies:
Other Carcinoma, Non-Small-Cell Lung Clinical Trials
Other California Clinical Trials
Other Vallejo Clinical Trials
Study of DN101 and Taxotere in patients with advanced non-small cell lung cancer
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