Paricalcitol and Gemcitabine in Treating Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Paricalcitol may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving paricalcitol together with gemcitabine may be an effective treatment for cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of paricalcitol when given together with gemcitabine in treating patients with advanced cancer.

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

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: Abbott
• Treatments: Ergocalciferols; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of advanced malignancy

• Metastatic or unresectable disease

• Standard curative or palliative measures do not exist or are no longer effective

• No known brain metastases

• Patients with previously treated brain metastases are eligible provided they have recovered from prior treatment

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 mg/dL

• AST and ALT ≤ 3.0 times upper limit of normal

Renal

• Creatinine ≤ 2.0 mg/dL

• Corrected calcium ≤ 10.5 mg/dL

• Prior single confirmed urolithiasis allowed provided patient is free of stone formation for ≥ 5 years

• No calculi in the urinary tract on kidney ultrasound biopsy or other imaging studies

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs

• No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• Curative therapy for a condition associated with the risk of renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patients have been free of stone formation for ≥ 5 years

• No concurrent digoxin

• No other concurrent investigational agents