Clinical trial · Interventional
Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer
- 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: Calcitriol may cause pancreatic cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may also help docetaxel work better by making the tumor cells more sensitive to the drug. Giving calcitriol together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving calcitriol together with docetaxel works in treating patients with metastatic or locally advanced pancreatic 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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcitriol | Dietary Supplement | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to progression
Secondary outcomes (4)
- measure
- Median and one-year survival
- measure
- Overall response
- measure
- Toxicity
- measure
- Change in pancreatic cancer-induced pain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of pancreatic cancer * Locally advanced or metastatic disease PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * Not specified Hematopoietic * White blood cell (WBC) \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL (transfusion allowed) Hepatic * Bilirubin \< 1.5 times upper limit of normal (ULN) * Alkaline phosphatase (AP) \< 5.0 times ULN * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \< 2.5 times ULN (if AP \< 2.5 times ULN) OR * ALT and AST \< 1.5 times ULN (if AP \> 2.5 times ULN and \< 5.0 times ULN) Renal * Creatinine \< 1.3 mg/dL * Calcium \< 10.5 mg/dL * Phosphate \< 4.7 mg/dL * No kidney stones within the past 5 years * No history of hypercalcemia Cardiovascular * No myocardial infarction within the past 3 months * No uncontrolled heart failure with a known ejection fraction \< 30% * No other significant heart disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80 * No peripheral neuropathy ≥ grade 2 * No comorbid condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for metastatic disease * No prior chemoradiotherapy for locally advanced disease * No prior adjuvant docetaxel * Other prior adjuvant chemotherapy allowed Endocrine therapy * Not specified Radiotherapy * See Chemotherapy * More than 2 weeks since prior radiotherapy Surgery * More than 30 days since prior investigational surgery Other * More than 7 days since prior and no concurrent digoxin or thiazide diuretic therapy * More than 30 days since prior investigational therapy * No concurrent magnesium-containing antacids, bile resin-binding drugs, or calcium supplements
References
Publications (0)
Data not yet available