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Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of pancreatic cancer

- Locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- 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

- ALT and 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Safety Issue:

No

Principal Investigator

Charles D. Blanke, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445077

NCT ID:

NCT00238199

Start Date:

June 2002

Completion Date:

August 2006

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098