Clinical trial NCT00238199: Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Official title: Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: stage III pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-10-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to progression
Secondary outcomes:
measure: Median and one-year survival
measure: Overall response
measure: Toxicity
measure: Change in pancreatic cancer-induced pain
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Charles D. Blanke, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References: