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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238199
• Other study ID #: CDR0000445077
• Secondary ID: OHSU-GIM-02007-L
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2005
• Last updated: April 22, 2015
• Start date: June 2002
• Est. completion date: August 2006

Study information

• Verified date: April 2015
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Dietary Supplement:
• calcitriol

Drug:
• docetaxel

Locations

Country	Name	City	State
United States	Oregon Health & Science University Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression			No
Secondary	Median and one-year survival			No
Secondary	Overall response			No
Secondary	Toxicity			Yes
Secondary	Change in pancreatic cancer-induced pain			No