Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

OHSU Knight Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Pancreatic Cancer

Treatments

Dietary Supplement: calcitriol

Drug: docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00238199

OHSU-GIM-02007-L

CDR0000445077

OHSU-1104

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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