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• W2247707042 abstract "e13031 Background: Calcitriol+ gemcitabine (G) combination results in synergistic antitumor effects in preclinical models. Cytidine deaminase (CDD) inactivates G into 2′,2′-difluorodeoxyuridine (dFdU) and its overexpression may lead to G resistance. Calcitriol decreases CDD activity in peripheral blood mononuclear cells (PBM). P is a potentially less hypercalcemic calcitriol analogue that is cytotoxic in vitro, and synergistic with several chemotherapeutic agents, including G. We are conducting a phase I study of P + fixed-dose G. The primary aim is to determine maximum tolerated dose (MTD) of the combination in patients (pts) with advanced cancer. Secondary aims are to evaluate toxicity, the effect of P on PK of G, CDD activity in PBM and clinical outcomes. Methods: Each cycle is 4 weeks: G 800 or 1,000 mg/m2 (over 80 or 100 min) weekly × 3, starting on day 1; P weekly, 24 h prior to G, starting on day 7. A standard 3+3 dose escalation schema was used. Planned P dose levels (DL) are 0.24, 0.72, 1.20, 1.8, 2.4, 3, 3.75, 4.69, 7μg/kg, and 50% increments till MTD. PK of G and CDD activity (PBM) were studied on days 1 and 8. PK of P are obtained on day 7. Results: Thirty-eight pts with the refractory solid tumors have been enrolled. Tumor types were lung 9, gastroesophageal 8, pancreas 7, liver 3, prostate 2, colorectal 3, unknown 2, breast, bladder, other GI and endocrine 1 each. Median age 62 yrs (range 26-80); M/F were 21/17; ECOG PS 0/1/2: 17/20/1; median cycle 2 (range 1-9). Two DLTs have occurred: 1 (thrombocytopenia, dose delay > 2 weeks) at DL6 and 1 (grade 3 somnolence) at DL9. Currently 3 of 6 pts have been enrolled at DL9. Best response was stable in 10/ 38 (26%) (median duration of 5.3 months) and partial response in 1(3%) for a disease control rate of 29% in refractory patients. Median (range) G exposure increased from 12 (6-16) to 25 (19-30) ug-hr/mL following doses of 1.2 and 7 ug/kg of P. Interestingly, dFdu also increased by less than 50% over the entire dose range tested. Inadequate yield of PBM limited the assessment of P effect on CDD levels. Conclusions: MTD has not been reached at 7μg/kg of P with G 800 mg/m2/week. G drug exposure increased in combination with P. Dose escalation is ongoing. No significant financial relationships to disclose." @default.
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• W2247707042 date "2010-05-20" @default.
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• W2247707042 title "Enhanced gemcitabine (G) exposure in combination with escalating doses of paricalcitol [19-nor-1 alpha, 25-(OH)2 D2] (P) in patients with advanced malignancies." @default.
• W2247707042 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.e13031" @default.
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