Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer
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
1 other identifier
interventional
80
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2003
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 6, 2003
CompletedFirst Posted
Study publicly available on registry
August 8, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMay 7, 2007
May 1, 2007
August 6, 2003
May 3, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novacealead
- Aventis Pharmaceuticalscollaborator
Study Sites (11)
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
Kaiser Permanente Medical Center (Northern California)
Vallejo, California, 94589, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
New York Oncology Hematology, P.C. - Albany Regional Cancer Center
Albany, New York, United States
Piedmont Hematology Oncology Associates, PLLC
Winston-Salem, North Carolina, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Yakima Regional Cancer Care Center
Yakima, Washington, 98902, United States
Related Publications (1)
Beer TM, Eilers KM, Garzotto M, Egorin MJ, Lowe BA, Henner WD. Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer. J Clin Oncol. 2003 Jan 1;21(1):123-8. doi: 10.1200/jco.2003.05.117.
PMID: 12506180BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Howard West, M.D.
Swedish Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 6, 2003
First Posted
August 8, 2003
Study Start
June 1, 2003
Study Completion
December 1, 2005
Last Updated
May 7, 2007
Record last verified: 2007-05