A Phase I Clinical Trial of Oral Calcitriol With Fixed Dose of Cisplatin and Gemcitabine in Patients With Advanced Solid Tumors

Inclusion Criteria

Inclusion Criteria

- Patients with a diagnosis of advanced unresectable non-hematological malignancy that
has no known standard of care or for which the use of gemcitabine plus cisplatin
constitutes a reasonable option

- Have an ECOG Performance Status of 0-1

- Have the following clinical values:

- WBC ≥ 3.0 x 10 to the 9th/L and Neutrophils ≥ 1.5 x 10 to the 9th/L and
platelets ≥ 100 x 10 to the 9th/L and Hgb ≥ 10g/dL

- Bilirubin ≤ institutional upper limit of normal (ULN); AST and ALT < 2.5 x
institutional ULN unless metastatic to liver in which case AST and AL T should
be < 5 x institutional ULN

- Creatinine ≤ 1.5 x institutional ULN

- Corrected calcium ≤ institutional ULN (corrected calcium = (4- Albumin) x 0.8 +
calcium)

- Patients of child-bearing potential must agree to use acceptable contraceptive
methods (e.g., double barrier) during treatment

- Patient or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

- No treatment with investigational agents within 4 weeks prior to study drug
administration

- No chemotherapy within 4 weeks prior to study treatment administration; nitrosoureas
and mitomycin C are not allowed within 6 weeks prior to initiation of study treatment

- Palliative radiation is allowed prior to enrollment as long as it is completed > 4
weeks from initiation of study treatment

- Patients should be able to take oral medications Exclusion Criteria

- Known hypersensitivity to any of the study drugs involved

- Brain metastases are excluded unless treated and shown to be controlled more than 2
months from completion of treatment and not associated with CNS symptoms

- History of hypercalcemia

- Evidence of nephrectomy

- History of (within 24 months prior to enrollment) of kidney, ureter, or bladder
stones or active kidney, ureteral, or bladder stones - with the exception of uric
acid stones

- Unwillingness to stop calcium supplementation or vitamin D supplementation

- Thiazide or digoxin therapy

- Pregnant or nursing female patients.

- Unwilling or unable to follow protocol requirements

- Any condition which in the Investigator's opinion deems the patient an unsuitable
candidate to receive study drug

- Received an investigational agent within 4 weeks prior to enrollment

- Nut allergy

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this study