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An Open Label, Dose Escalation Study of Paricalcitol (Zemplar™) [19-NOR-1 ALPHA, 25-(OH) D] in Combination With Gemcitabine [2', 2' -Difluorodeoxycytidine] in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

An Open Label, Dose Escalation Study of Paricalcitol (Zemplar™) [19-NOR-1 ALPHA, 25-(OH) D] in Combination With Gemcitabine [2', 2' -Difluorodeoxycytidine] in Patients With Advanced Malignancies


OBJECTIVES:

Primary

- Determine the maximum tolerated dose (MTD) of paricalcitol when given with gemcitabine
in patients with advanced malignancy.

Secondary

- Determine safety and toxicity of this regimen in these patients.

- Determine the pharmacokinetics of these regimens in these patients.

- Determine the clinical outcome (overall survival and best overall response) of patients
treated with this regimen.

OUTLINE: This is a dose-escalation, open-label study.

Patients receive gemcitabine IV over 80 minutes on days 1, 8, and 15 and paricalcitol IV
over 15 minutes on days 7 and 14 in course 1. Beginning in course 2, patients receive
paricalcitol IV over 15 minutes on days 1, 8, and 15 and gemcitabine IV over 80 minutes on
days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paricalcitol until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the
MTD.

After completion of study treatment, patients are followed for survival.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of advanced malignancy

- Metastatic or unresectable disease

- Standard curative or palliative measures do not exist or are no longer effective

- No known brain metastases

- Patients with previously treated brain metastases are eligible provided they
have recovered from prior treatment

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- At least 3 months

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 mg/dL

- AST and ALT ≤ 3.0 times upper limit of normal

Renal

- Creatinine ≤ 2.0 mg/dL

- Corrected calcium ≤ 10.5 mg/dL

- Prior single confirmed urolithiasis allowed provided patient is free of stone
formation for ≥ 5 years

- No calculi in the urinary tract on kidney ultrasound biopsy or other imaging studies

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 3 months
after completion of study treatment

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to study drugs

- No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

- Not specified

Radiotherapy

- More than 4 weeks since prior radiotherapy and recovered

Surgery

- Not specified

Other

- Curative therapy for a condition associated with the risk of renal stones (e.g.,
hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided
patients have been free of stone formation for ≥ 5 years

- No concurrent digoxin

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) of i. v. pancalcitol given weekly, in combination with fixed dose rate infusion of i. v.gemcitabine given weekly in patients with advanced malignancies.

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Renuka Iyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000441212

NCT ID:

NCT00217477

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263