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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.
 
ClinicalTrials.gov Identifier: NCT00008086
Recruitment Status : Completed
First Posted : September 4, 2003
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Laura A. Pollice, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE January 6, 2001
First Posted Date  ICMJE September 4, 2003
Last Update Posted Date December 19, 2013
Study Start Date  ICMJE January 1996
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00008086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase I Trial of Subcutaneous And/Or Oral Calcitriol [(1,25-COH)2D3] and Carboplatin in Advanced Solid Tumors
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.

Detailed Description

OBJECTIVES:

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Dietary Supplement: calcitriol
  • Drug: carboplatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

  • 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

Cardiovascular:

  • No unstable angina
  • No symptomatic coronary artery disease

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • Not specified

Other:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00008086
Other Study ID Numbers  ICMJE 97-004
CDR0000068374 ( Registry Identifier: PDQ (Physician Data Query) )
PCI-IRB-970532
NCI-G00-1885
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laura A. Pollice, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Ramesh K. Ramanathan, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP