History of calcium oxalate stones
Serum calcium within normal institutional limits
Calcium within normal range (supplementation is allowed)
Patients with contraindication to use leucovorin calcium (calcium folinate), 5-fluorouracil, and oxaliplatin (FOLFOX) chemotherapy and pelvic radiation.
Calcium WNL
Corrected calcium value =< 1.1 x upper limit of normal (ULN)
History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
Corrected calcium at or below ULN
Corrected calcium WNL
Use of medications that increase serum levels of phosphorus and/or calcium (e.g., calcium, phosphate, vitamin D, parathyroid hormone)
Total calcium (corrected for serum albumin) before the first dose of ceritinib
Hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory’s normal parameters
Patients must have corrected calcium and phosphate < upper limit or normal (ULN) obtained within 7 days prior to sub-study registration
Patients must have corrected calcium and phosphate < ULN obtained within 7 days prior to sub-study registration
Serum calcium within normal limits
Total calcium (corrected for serum calcium) =< ULN (or corrected to =< ULN with supplements prior to registration), obtained =< 21 days prior to registration
Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
Serum calcium levels outside the laboratory’s reference range
History of a calcium/phosphate homeostasis disorder
Subjects with a history of calcium oxalate nephrolithiasis are excluded
Plasma calcium > 8.5 and < 10.5
Total calcium (corrected for serum albumin)
Corrected serum calcium ? ULN
Serum calcium (corrected for albumin level) =< 1x institutional ULN
Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional ULN, corrected for albumin level if albumin is not within institutional limits of normal); the use of supplemental calcium is prohibited while on study
Normal serum calcium (or normal corrected serum calcium)
Calcium levels must be normalized and maintained within normal limits for study entry and while on treatment
Normal corrected calcium levels
Corrected calcium =< institutional ULN (corrected calcium = (4- Albumin) x 0.8 + calcium)
Calcium: not above normal institutional limit
Serum calcium > 8.4; electrolyte repletion is allowed to reach these values
No dietary supplements allowed during the study period, except multivitamins, vitamin D and calcium.
Patient has a corrected serum calcium ?ULN.
Corrected serum calcium concentration within normal range per local clinical laboratory standard
Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately high for associated calcium level
Fatigue brought on by conditions other than cancer such as (the indicated tests are required only if that mechanism of fatigue is suspected):\r\n* Uncontrolled hypothyroidism (thyroid-stimulating hormone [TSH] > 10 IU)\r\n* Hypercalcemia (calcium > 11 mg/dL) calcium (Ca)=SerumCA + 0.8* (Normal/Albumin –PatientAlbumin)\r\n* Decompensated congestive heart failure\r\n* Chronic obstructive pulmonary disease requiring oxygen replacement
Subjects with any pathology associated with altered serum calcium levels
If taking more than 1000 mg/day of elemental calcium, must be willing and able to discontinue or reduce their calcium use and/or use non-calcium based therapies for the duration of the study
Has history of calcium oxalate stones
History of known abnormalities in calcium metabolism
Hypercalcemia (serum calcium in excess of laboratory upper limit of normal [ULN])
Participants with a calcium intake >= 700 mg/day measuring with 24 hour dietary recalls
Participants with a calcium intake < 2000 mg/day measuring with 24 hour dietary recalls
Serum calcium =< institutional ULN
Acute liver disease, unexplained transaminase elevations, or elevated serum calcium
History of known abnormalities in calcium metabolism
Hypercalcemia (serum calcium in excess of laboratory upper limit normal [ULN])
Has serum calcium less than or equal to ULN (for patients with an albumin lower than 3.0, a corrected calcium serum calcium = serum calcium +[0.8][3.5-serum albumin]) within 72 hours prior to registration
Patients receiving calcium-lowering therapy or drugs that may affect calcium levels (e.g., calcitonin, mithramycin, phosphate, denosumab) within 4 weeks of initiation of topical calcitriol. Patients who have been managed with bisphosphonates or calcium-lowering therapy for 3 months or greater prior to the start of the trial and have demonstrated evidence for stability of calcium metabolism would be considered eligible for participation in the trial.
Patients treated with medications that are known to affect calcium levels within 4 weeks of initiation of topical therapy (>500 IU vitamin A, calcium supplements, fluoride, antiepileptics).with the exception of subjects on stable therapy for more than six months
Calcium within 2 x ULN
Participants must have serum calcium (corrected for albumin level) =< 1 x institutional upper limit of normal (ULN)
Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional ULN, corrected for albumin level if albumin is not within institutional limits of normal)\r\n* The use of supplemental calcium or supplements containing calcium is prohibited during the treatment period of this clinical trial
Total calcium (corrected for serum albumin)