Clinical trial · Interventional
Paricalcitol and Gemcitabine in Treating Patients With Advanced Cancer
An Open Label, Dose Escalation Study of Paricalcitol (Zemplar™) [19-NOR-1 ALPHA, 25-(OH) D] in Combination With Gemcitabine [2', 2' -Difluorodeoxycytidine] in Patients With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| paricalcitol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paricalcitol IV in combination with Gemcitabine IV
- description
- Patients receive gemcitabine hydrochloride IV over 80 minutes on days 1, 8, and 15 and paricalcitol IV over 15 minutes on days 7 and 14 in course 1. Beginning in course 2, patients receive paricalcitol IV over 15 minutes on days 1, 8, and 15 and gemcitabine hydrochloride IV over 80 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: paricalcitol
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose (MTD) of i. v. pancalcitol given weekly, in combination with fixed dose rate infusion of i. v.gemcitabine given weekly in patients with advanced malignancies.
- timeFrame
- 4 weeks
Secondary outcomes (6)
- measure
- To assess toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available