Trial record 1 of 1 for:    NCT00217477
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Paricalcitol and Gemcitabine in Treating Patients With Advanced Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00217477
First received: September 20, 2005
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

RATIONALE: Paricalcitol may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving paricalcitol together with gemcitabine may be an effective treatment for cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of paricalcitol when given together with gemcitabine in treating patients with advanced cancer.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
Drug: paricalcitol
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess toxicity. [ Time Frame: 8 week intervals ] [ Designated as safety issue: Yes ]
  • To determine the effects of paricalcitol on the pharmacokinetics of gemcitabine. [ Time Frame: Days 1 & 8, cycle 1 ] [ Designated as safety issue: Yes ]
  • To determine the effects of pariclcitol on cytidine deaminase in PBM [ Time Frame: Days 1 & 8, cycle 1 ] [ Designated as safety issue: No ]
  • To determine the effects of paricalcitol on dFdCTP in PBM [ Time Frame: Days 1 & 8, cycle 1 ] [ Designated as safety issue: No ]
  • To determine the pharmacokinetics of paricalcitol when given with gemcitabine [ Time Frame: Day 7, cycle 1 ] [ Designated as safety issue: No ]
  • To describe clinical outcome for response and survival [ Time Frame: 8 week intervals ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: August 2004
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paricalcitol IV in combination with Gemcitabine IV
Patients receive gemcitabine hydrochloride 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 hydrochloride IV over 80 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: gemcitabine hydrochloride
Given IV
Drug: paricalcitol
Given IV

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217477

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Abbott
Investigators
Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00217477     History of Changes
Other Study ID Numbers: CDR0000441212
Study First Received: September 20, 2005
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Ergocalciferols
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Bone Density Conservation Agents
Enzyme Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 30, 2014