Skip to content

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00238199
Enrollment
25
Registered
2005-10-13
Start date
2002-06-30
Completion date
2006-08-31
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancer, stage IV pancreatic cancer

Brief summary

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.

Detailed description

OBJECTIVES: Primary * Determine the time to progression in patients with metastatic or locally advanced pancreatic cancer treated with calcitriol and docetaxel. Secondary * Determine the median and one-year survival of patients treated with this regimen. * Determine the overall response in patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Determine the change in pancreatic cancer-induced pain in patients treated with this regimen. OUTLINE: Patients receive oral calcitriol on days 1, 8, and 15 and docetaxel IV over 15-30 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Interventions

DIETARY_SUPPLEMENTcalcitriol
DRUGdocetaxel

Sponsors

Sanofi
CollaboratorINDUSTRY
OHSU Knight Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Time to progression

Secondary

MeasureTime frame
Median and one-year survival
Overall response
Toxicity
Change in pancreatic cancer-induced pain

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026