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Sponsors and Collaborators: |
University of Michigan Cancer Center National Institutes of Health (NIH) |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00794547 |
According to the Cancer Atlas, lung cancer remains the major cancer among the 10.9 million new cases of cancer diagnosed annually worldwide. The mortality from lung cancer is greater than the combined mortality for breast, colon and prostate cancer combined. Most patients with metastatic non-small-cell lung cancer (NSCLC) are treated with platinum-based chemotherapy regimens. The drug combination of cisplatin and docetaxel is one of the commonly used regimens in metastatic NSCLC. Although both drugs are powerful disruptors of cell growth, positive therapeutic response rates to this therapy remain low for NSCLC patients, from 25% to 30%. While adding new biologics such as bevacizumab to the current treatment standard can improve treatment response, median survival for advanced NSCLC patients receiving this type of treatment remains low at under 12 months. Research studies have demonstrated that Vitamin D, and it's signaling pathways are important biological targets in cancer therapeutics. In vitro and in vivo calcitriol (1, 25 dihydroxycholcalciferol) is antiproliferative and potentiates the antitumor effects of cytotoxic agents (e.g. taxanes, platinum analogues). We have shown that administration of high doses of calcitriol and cisplatin is feasible and associated with complete tumor regressions in dogs with spontaneous cancers. Calcitriol has also shown to be synergistic with docetaxel both in preclinical as well as in a recent phase II clinical trial in prostate cancer. Based on these results and other supporting data from studies indicating that calcitriol functions as a potent and well tolerated anti-tumor agent when used in combination with drugs likes cisplatin and docetaxel, we hypothesize that introducing calcitriol into treatment regimes for NSCLC patients has the potential to demonstrably improve treatment response for these patients. The overall goals for conducting this phase I/II clinical study will be (1) to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of calcitriol in combination with cisplatin/docetaxel in patients with advanced NSCLC, (2) to assess the response rates of patients with advanced NSCLC to the combination of calcitriol with cisplatin/docetaxel, (3) to evaluate the pharmacokinetics (PK) of administering calcitriol intravenously at the MTD, and (4) to evaluate correlations between calcitriol PK and changes on specific coding regions of the gene associated with calcitriol breakdown.
Condition | Intervention | Phase |
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Non Small Cell Lung Cancer |
Drug: Calcitriol |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Clinical Trial of Intravenous (IV) Calcitriol With Fixed Dose of Cisplatin and Docetaxel in Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 57 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2015 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
In the Phase I part of the study, we will test the safety of calcitriol along with standard chemotherapy. In addition, the goal is to see what effects (good and bad) it has on you and your type of Non-Small Cell Lung Cancer. This study is ongoing. In this portion of the study, we are testing increasing doses of calcitriol in combination with standard chemotherapy. If 2/3 patients at any dose level experience side effects that are limiting, we will call the dose level below that dose the maximum tolerated dose.
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Drug: Calcitriol
80 mcg Calcitriol will be infused IV over 1 hour every 21 days.
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2: Experimental
In the Phase II part of the study, we will find out the response your cancer has to the combination of a fixed dose of calcitriol (determined in the phase I study) with standard chemotherapy.
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Drug: Calcitriol
In this portion of the study, all patients will get the same dose of calcitriol (determined from the Phase I study) along with the standard chemotherapy
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with IIIB NSCLC who are eligible for definitive chemoradiation.
Contact: Nithya Ramnath, MD | 800-865-1125 | nithyar@med.umich.edu |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 |
Responsible Party: | University of Michigan Comprehensive Cancer Center ( Nithya Ramnath, MD ) |
Study ID Numbers: | UMCC 2008.042, HUM%21242 |
Study First Received: | November 19, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00794547 |
Health Authority: | United States: Institutional Review Board |
lung cancer; nsclc |
Docetaxel Thoracic Neoplasms Calcium, Dietary Non-small cell lung cancer Cisplatin Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Calcitriol Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Calcium Channel Agonists Bone Density Conservation Agents Cardiovascular Agents |
Pharmacologic Actions Membrane Transport Modulators Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Vasoconstrictor Agents Micronutrients |