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Pancreatic CancerPhase 2NCT00238199

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

A Phase 2 study testing calcitriol and docetaxel in people with Pancreatic Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
calcitriol and docetaxel
How many people
25 participants
Where
1 siteUnited States
Study dates
Jun 2002to Aug 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University Cancer Institute

    Portland, Oregon, 97239-3098

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
calcitriol, docetaxel
Keywords
stage III pancreatic cancer, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression

Secondary outcomes (4)

  1. Median and one-year survival

  2. Overall response

  3. Toxicity

  4. Change in pancreatic cancer-induced pain

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2005 (estimated)
  2. Study startJun 2002
  3. Primary completionAug 2006
  4. Study completionAug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00238199
Sponsor's protocol ID
CDR0000445077
Other IDs
OHSU-GIM-02007-L, OHSU-1104
Status last verified
Apr 2015
First submitted
12 Oct 2005
Last updated
24 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing calcitriol and docetaxel in people with Pancreatic Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00238199.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.

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