Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00066885
- Lead Sponsor
- Novacea
- Brief Summary
This Phase 1/2 clinical trial is a multi-center, open-label study with three main objectives. The first (Phase 1A) is to determine the maximum-tolerated dose of DN-101 when administered in combination with Taxotere (docetaxel) every three weeks (closed). The second is to determine the maximum-tolerated dose of DN-101 when administered weekly in combination with Taxotere(docetaxel)devery three weeks (open). The third 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Histopathologically or cytologically proven non-small cell carcinoma of the lung (NSCLC), either Stage IIIB or Stage IV, that has progressed on or after first or second-line 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
New York Oncology Hematology, P.C. - Albany Regional Cancer Center
🇺🇸Albany, New York, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Yakima Regional Cancer Care Center
🇺🇸Yakima, Washington, United States
Northwest Cancer Specialists, P.C.
🇺🇸Vancouver, Washington, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Kaiser Permanente Medical Center (Northern California)
🇺🇸Vallejo, California, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Piedmont Hematology Oncology Associates, PLLC
🇺🇸Winston-Salem, North Carolina, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Kaiser Permanente Northwest
🇺🇸Portland, Oregon, United States