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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
calcitriol
docetaxel
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University Cancer Institute

Outcomes

Primary Outcome Measures

Time to progression

Secondary Outcome Measures

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

Full Information

First Posted
October 12, 2005
Last Updated
April 22, 2015
Sponsor
OHSU Knight Cancer Institute
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00238199
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
calcitriol
Intervention Type
Drug
Intervention Name(s)
docetaxel
Primary Outcome Measure Information:
Title
Time to progression
Secondary Outcome Measure Information:
Title
Median and one-year survival
Title
Overall response
Title
Toxicity
Title
Change in pancreatic cancer-induced pain

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles D. Blanke, MD, FACP
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States

12. IPD Sharing Statement

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

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