NCT00238199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jun 2002

Typical duration for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

4.2 years

First QC Date

October 12, 2005

Last Update Submit

April 22, 2015

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Time to progression

Secondary Outcomes (4)

  • Median and one-year survival

  • Overall response

  • Toxicity

  • Change in pancreatic cancer-induced pain

Interventions

calcitriolDIETARY_SUPPLEMENT
docetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

CalcitriolDocetaxel

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Charles D. Blanke, MD, FACP

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

June 1, 2002

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

US(1)