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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors

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Trial Information

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


PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of oral calcitriol when
combined with a standard dose of gemcitabine and cisplatin in a 28-day cycle. SECONDARY
OBJECTIVES: I. Describe the toxicity of this combination using CTCAE version 4.0. II. Study
the pharmacokinetics of calcitrio1 at the MTD in an expanded cohort of 6 patients. III.
Describe the clinical activity associated with this regimen in this advanced solid tumor
population. OUTLINE: Patients receive oral calcitriol on days 1, 2, 8, 9, 15 and 16;
cisplatin IV over 2 hours on day 2; and gemcitabine hydrochloride IV over 30 minutes on days
2, 9, 16. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity. After completion of study treatment, patients are followed at 30 days.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of oral calcitriol when combined with a standard dose of gemcitabine and cisplatin

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Grace K Dy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 163509

NCT ID:

NCT01093092

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263