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Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00008086
Recruitment Status : Completed
First Posted : September 4, 2003
Last Update Posted : December 19, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Laura A. Pollice, University of Pittsburgh

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may help solid tumor cells develop into normal cells. Combining calcitriol with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with carboplatin in treating patients who have advanced solid tumors.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific Dietary Supplement: calcitriol Drug: carboplatin Phase 1

Detailed Description:


  • Determine the maximum tolerated doses of calcitriol and carboplatin, when given in combination, in patients with advanced solid tumors.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the effect of calcitriol on the pharmacokinetics of carboplatin in these patients.
  • Correlate the pharmacokinetics of carboplatin with the myelosuppression following this regimen in these patients.
  • Determine the safety and efficacy of this regimen in patients with malignant glioma.

OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (brain tumor vs other solid tumor) and accrued in parallel. Patients are assigned to one of two treatment groups.

  • Group 1: Patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol subcutaneously (SC) or orally daily on days 2-4 for the first course only. For subsequent courses, patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3.
  • Group 2: Patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3 for the first, third, and subsequent courses. For the second course only, patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol SC or orally daily on days 2-4.

In both groups, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Sequential dose escalation of calcitriol is followed by sequential dose escalation of carboplatin. Cohorts of 3-6 patients receive escalating doses of calcitriol and then carboplatin until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 18-50 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Subcutaneous And/Or Oral Calcitriol [(1,25-COH)2D3] and Carboplatin in Advanced Solid Tumors
Study Start Date : January 1996
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced solid tumor that is not curable by standard therapy, including glioma and other brain tumors
  • Brain metastases allowed following definitive radiotherapy



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 4 times normal


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • Creatinine no greater than 2.0 mg/dL
  • Calcium no greater than 10.5 mg/dL


  • No unstable angina
  • No symptomatic coronary artery disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of barrier contraception AND 1 form of hormonal contraception for at least 1 week before, during, and for at least 2 weeks after study
  • No active infection
  • No other concurrent serious condition


Biologic therapy:

  • At least 4 weeks since prior biologic therapy (regional or systemic)


  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • No concurrent glucocorticoids as antiemetics
  • Concurrent exogenous glucocorticoids allowed for treatment of gliomas or other brain tumors


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy


  • Not specified


  • Dietary calcium intake of no more than 200-250 mg/day beginning 48 hours before each course and continuing for 7 days
  • No concurrent dairy products, green leafy vegetables, molasses, baking powder, fortified cereals, and dry peas and beans

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00008086

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United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Sponsors and Collaborators
University of Pittsburgh
National Cancer Institute (NCI)
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Study Chair: Ramesh K. Ramanathan, MD University of Pittsburgh
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Responsible Party: Laura A. Pollice, Clinical Research Manager, University of Pittsburgh Identifier: NCT00008086    
Other Study ID Numbers: 97-004
CDR0000068374 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 4, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013
Keywords provided by Laura A. Pollice, University of Pittsburgh:
recurrent adult brain tumor
adult brain stem glioma
adult craniopharyngioma
adult medulloblastoma
adult meningioma
adult glioblastoma
unspecified adult solid tumor, protocol specific
adult anaplastic astrocytoma
adult myxopapillary ependymoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult central nervous system germ cell tumor
adult pilocytic astrocytoma
adult subependymoma
adult ependymoblastoma
adult pineocytoma
adult pineoblastoma
adult meningeal hemangiopericytoma
adult choroid plexus tumor
adult grade III meningioma
adult oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Bone Density Conservation Agents