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Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00008086
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Pittsburgh
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ramesh K. Ramanathan, MD
Principal Investigator Affiliation University of Pittsburgh
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Unspecified Adult Solid Tumor, Protocol Specific
Additional Details

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.#46;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.

Contact a Trial Team

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Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489

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