Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsors and Collaborators:	UPMC Cancer Centers National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00008086

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Calcitriol Carboplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Trial of Subcutaneous And/Or Oral Calcitriol [(1,25-COH)2D3] and Carboplatin in Advanced Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 1996

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

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

UPMC Cancer Centers

National Cancer Institute (NCI)

Investigators

Study Chair:

Ramesh K. Ramanathan, MD

UPMC Cancer Centers

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068374, PCI-97-004, PCI-IRB-970532, NCI-G00-1885
Study First Received:	January 6, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00008086 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Glioblastoma
Choroid Plexus Neoplasms
Bone Density Conservation Agents
Central Nervous System Neoplasms
Ependymoma
Calcitriol
Vitamins
Craniopharyngioma
Vasoconstrictor Agents
Meningioma
Glioma
Micronutrients
Nervous System Neoplasms

Astrocytoma
Trace Elements
Carboplatin
Cardiovascular Agents
Hemangiopericytoma
Recurrence
Brain Neoplasms
Calcium, Dietary
Medulloblastoma
Oligodendroglioma
Gliosarcoma
Pinealoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Calcium Channel Agonists
Nervous System Diseases
Physiological Effects of Drugs
Bone Density Conservation Agents
Cardiovascular Agents
Central Nervous System Neoplasms
Carboplatin

Pharmacologic Actions
Calcitriol
Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Micronutrients
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009