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Status:

COMPLETED

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

Lead Sponsor:

OHSU Knight Cancer Institute

Collaborating Sponsors:

Sanofi

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 sto...

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 an...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2002

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2006

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT00238199

    Start Date

    June 1 2002

    End Date

    August 1 2006

    Last Update

    April 24 2015

    Active Locations (1)

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    Oregon Health & Science University Cancer Institute

    Portland, Oregon, United States, 97239-3098