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Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00066885
First Posted: August 8, 2003
Last Update Posted: May 7, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Novacea
  Purpose
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.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Drug: calcitriol + docetaxel Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novacea:

Estimated Enrollment: 80
Study Start Date: June 2003
Estimated Study Completion Date: December 2005
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066885


Locations
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
Kaiser Permanente Medical Center (Northern California)
Vallejo, California, United States, 94589
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States
United States, New York
New York Oncology Hematology, P.C. - Albany Regional Cancer Center
Albany, New York, United States
United States, North Carolina
Piedmont Hematology Oncology Associates, PLLC
Winston-Salem, North Carolina, United States
United States, Oklahoma
Cancer Care Associates
Tulsa, Oklahoma, United States
United States, Oregon
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Yakima Regional Cancer Care Center
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Novacea
Aventis Pharmaceuticals
Investigators
Study Chair: Howard West, M.D. Swedish Cancer Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00066885     History of Changes
Other Study ID Numbers: DN101-004
First Submitted: August 6, 2003
First Posted: August 8, 2003
Last Update Posted: May 7, 2007
Last Verified: May 2007

Keywords provided by Novacea:
DN101
Calcitriol
Lung Cancer
NSCLC
Taxotere

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Calcitriol
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents