Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laura A. Pollice, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00008086
First received: January 6, 2001
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Study Start Date: January 1996
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00008086

Locations
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Sponsors and Collaborators
University of Pittsburgh
Investigators
Study Chair: Ramesh K. Ramanathan, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Laura A. Pollice, Clinical Research Manager, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00008086     History of Changes
Other Study ID Numbers: 97-004, CDR0000068374, PCI-IRB-970532, NCI-G00-1885
Study First Received: January 6, 2001
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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:
Central Nervous System Neoplasms
Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Calcitriol
Carboplatin
Antineoplastic Agents
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014