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

NCT ID: NCT00066885

Last Updated: 2007-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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calcitriol + docetaxel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aventis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Novacea

INDUSTRY

Sponsor Role lead

Principal Investigators

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Howard West, M.D.

Role: STUDY_CHAIR

Swedish Cancer Institute

Locations

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Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Site Status

Kaiser Permanente Medical Center (Northern California)

Vallejo, California, United States

Site Status

Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status

New York Oncology Hematology, P.C. - Albany Regional Cancer Center

Albany, New York, United States

Site Status

Piedmont Hematology Oncology Associates, PLLC

Winston-Salem, North Carolina, United States

Site Status

Cancer Care Associates

Tulsa, Oklahoma, United States

Site Status

Kaiser Permanente Northwest

Portland, Oregon, United States

Site Status

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

Site Status

Yakima Regional Cancer Care Center

Yakima, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12506180 (View on PubMed)

Other Identifiers

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DN101-004

Identifier Type: -

Identifier Source: org_study_id