Status:
COMPLETED
Paricalcitol and Gemcitabine in Treating Patients With Advanced Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
Abbott
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 g...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of paricalcitol when given with gemcitabine in patients with advanced malignancy. Secondary * Determine safety and toxicity of this...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00217477
Start Date
August 1 2004
End Date
September 1 2014
Last Update
December 9 2014
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001