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A PHASE I/II CLINICAL TRIAL OF INTRAVENOUS (I.V.) CALCITRIOL WITH FIXED DOSES OF

Award Number: R21CA128193
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2008
PERIOD OF PERFORMANCE END DATE: 01/30/2010

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A PHASE I/II CLINICAL TRIAL OF INTRAVENOUS (I.V.) CALCITRIOL WITH FIXED DOSES OF - DESCRIPTION (provided by applicant): 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2009 ( Subtotal = $378,381 )
2009	2009	UNIVERSITY OF MICHIGAN	3003 S STATE ST 3089 WOLVERINE	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	005	3	3/18/2009	NON-COMPETING CONTINUATION	$37,838
2009	2009	UNIVERSITY OF MICHIGAN	3003 S STATE ST 3089 WOLVERINE	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	004	3	2/20/2009	NON-COMPETING CONTINUATION	$340,543
2009	2008	UNIVERSITY OF MICHIGAN	3003 S STATE ST 3089 WOLVERINE	ANN ARBOR	MI	48109	WASHTENAW	USA	Cancer Treatment Research	003	2	12/24/2008	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$198,633
2009	2008	NY ST DEPARTMENT OF HEALTH & HEALTH RESEARCH, INC	666 ELM STREET	BUFFALO	NY	14263	ERIE	USA	Cancer Treatment Research	002	1	12/23/2008	NEW	-$198,633
2009	2008	NY ST DEPARTMENT OF HEALTH & HEALTH RESEARCH, INC	666 ELM STREET	BUFFALO	NY	14263	ERIE	USA	Cancer Treatment Research	001	1	12/8/2008	NEW	$412,976
2009	2008	NY ST DEPARTMENT OF HEALTH & HEALTH RESEARCH, INC	666 ELM STREET	BUFFALO	NY	14263	ERIE	USA	Cancer Treatment Research	000	1	12/5/2008	NEW	-$412,976
														Subtotal = $378,381

Issue Date FY: 2008 ( Subtotal = $412,976 )
2008	2008	HEALTH RESEARCH, INC - ROSWELL PARK DIVISION	666 ELM STREET	BUFFALO	NY	14203	ERIE	USA	Cancer Treatment Research	000	1	1/23/2008	NEW	$412,976
														Subtotal = $412,976

Grand Total All Awards = $791,357

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A PHASE I/II CLINICAL TRIAL OF INTRAVENOUS (I.V.) CALCITRIOL WITH FIXED DOSES OF

Award Number: R21CA128193

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2008

PERIOD OF PERFORMANCE END DATE: 01/30/2010

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