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

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00066885
First received: August 6, 2003
Last updated: May 3, 2007
Last verified: May 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00066885     History of Changes
Other Study ID Numbers: DN101-004
Study First Received: August 6, 2003
Last Updated: May 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Novacea:
DN101
Calcitriol
Lung Cancer
NSCLC
Taxotere

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

ClinicalTrials.gov processed this record on October 23, 2014