Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcitriol; Carboplatin

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