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Carcinoma, Non-Small-Cell LungPhase 1/2NCT00066885

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

A Phase 1/2 study testing calcitriol + docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Novacea at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
calcitriol + docetaxel
How many people
80 participants
Where
11 sitesUnited States
Study dates
Jun 2003to Dec 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

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

    Albany, New York

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Rocky Mountain Cancer Center

    Denver, Colorado

  • Cancer Centers of the Carolinas

    Greenville, South Carolina

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Cancer Care Associates

    Tulsa, Oklahoma

  • Kaiser Permanente Medical Center (Northern California)

    Vallejo, California, 94589

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington

  • Piedmont Hematology Oncology Associates, PLLC

    Winston-Salem, North Carolina

  • Yakima Regional Cancer Care Center

    Yakima, Washington, 98902

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
calcitriol + docetaxel
Keywords
DN101, Calcitriol, Lung Cancer, NSCLC, Taxotere
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • calcitriol + docetaxelDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2003 (estimated)
  2. Study startJun 2003
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066885
Sponsor's protocol ID
DN101-004
Status last verified
May 2007
First submitted
6 Aug 2003
Last updated
7 May 2007
Results posted
No

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. doi: 10.1200/jco.2003.05.117.

    PubMed 12506180

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing calcitriol + docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Novacea at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066885, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2007.

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