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.

Condition	Treatment or Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: calcitriol + docetaxel	Phase I Phase II

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Kathyrn Woody      650- 228-1839    woody@novacea.com
Alan Arroyo      650- 228-1803    arroyo@novacea.com

California
      Alta Bates Comprehensive Cancer Center, Berkeley,  California,  94704,  United States; Recruiting
      Kaiser Permanente Medical Center (Northern California), Vallejo,  California,  94589,  United States; Recruiting
Colorado
      Rocky Mountain Cancer Center, Denver,  Colorado,  United States; Recruiting
Montana
      Hematology-Oncology Centers of the Northern Rockies, Billings,  Montana,  59101,  United States; Recruiting
New York
      New York Oncology Hematology, P.C. - Albany Regional Cancer Center, Albany,  New York,  United States; Recruiting
North Carolina
      Piedmont Hematology Oncology Associates, PLLC, Winston Salem,  North Carolina,  United States; Recruiting
Oklahoma
      Cancer Care Associates, Tulsa,  Oklahoma,  United States; Recruiting
Oregon
      Kaiser Permanente Northwest, Portland,  Oregon,  97227,  United States; Recruiting
South Carolina
      Cancer Centers of the Carolinas, Greenville,  South Carolina,  United States; Recruiting
Washington
      Yakima Regional Cancer Care Center, Yakima,  Washington,  98902,  United States; Recruiting
      Swedish Cancer Institute, Seattle,  Washington,  98104,  United States; Recruiting
      Rainer Oncology Professional Services, Puyallup,  Washington,  98372,  United States; Recruiting
      Northwest Cancer Specialists, P.C., Vancouver,  Washington,  United States; Recruiting

Study chairs or principal investigators

Howard West, M.D.,  Study Chair,  Swedish Cancer Institute   

Study ID Numbers:  DN101-004
Record last reviewed:  September 2004
Record first received:  August 6, 2003
ClinicalTrials.gov Identifier:  NCT00066885
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10