Know Cancer

or
forgot password

A Phase 1/2 Multicenter, Open Label, Dose Ranging Study of DN-101 and Taxotere® in Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Previous Therapy With Platinum-Based Chemotherapy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Phase 1/2 Multicenter, Open Label, Dose Ranging Study of DN-101 and Taxotere® in Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Previous Therapy With Platinum-Based Chemotherapy


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.


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 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Howard West, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Swedish Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

DN101-004

NCT ID:

NCT00066885

Start Date:

June 2003

Completion Date:

December 2005

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • DN101
  • Calcitriol
  • Lung Cancer
  • NSCLC
  • Taxotere
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Swedish Cancer InstituteSeattle, Washington  98104
Rocky Mountain Cancer CenterDenver, Colorado  80218
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
New York Oncology Hematology, P.C. - Albany Regional Cancer CenterAlbany, New York  12208
Yakima Regional Cancer Care CenterYakima, Washington  89802
Cancer Care AssociatesTulsa, Oklahoma  74136
Kaiser Permanente Medical Center (Northern California)Vallejo, California  94589
Piedmont Hematology Oncology Associates, PLLCWinston-Salem, North Carolina  
Kaiser Permanente NorthwestPortland, Oregon  97227
Northwest Cancer Specialists, P.C.Vancouver, Washington