Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer
Information source: Novacea
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma, Non-Small-Cell Lung
Intervention: calcitriol + docetaxel (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Novacea Official(s) and/or principal investigator(s):
Howard West, M.D., Study Chair, Affiliation: Swedish Cancer Institute
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Yakima Regional Cancer Care Center, Yakima, Washington 98902, United States
Swedish Cancer Institute, Seattle, Washington 98104, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Additional Information
Novacea Web Page
Related publications: 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.
Starting date: June 2003
Ending date: December 2005
Last updated: May 3, 2007
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