Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer

This study is currently recruiting participants.
Verified January 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01748500
First received: December 10, 2012
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

The main objectives of this trial are:

  1. To assess the activity and safety of pantoprazole and docetaxel (with prednisone) in men with metastatic CRPC who have not received prior chemotherapy.
  2. To evaluate archival prostate cancer tissue of men included in the clinical trial for evidence of autophagy using IHC for LC3B, ATG5, p62 as well as ERG.
  3. To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.

Condition Intervention Phase
Prostate Cancer
Drug: Pantoprazole
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer - a Single Arm Phase II Clinical Trial With a Predefined Reference Group (PANDORA)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Confirmed PSA response [ Time Frame: 20 months ] [ Designated as safety issue: No ]
    The primary endpoint is met if PSA falls to ≤50% of baseline, maintained for ≥3 weeks.


Estimated Enrollment: 32
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pantoprazole, Docetaxel, Prednisone Drug: Pantoprazole
Other Name: Pantoprazole sodium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18yrs
  • ECOG performance status ≤2
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Clinical or radiological evidence of metastatic disease
  • Disease progression while receiving androgen deprivation therapy with an increase in PSA of 25% or greater over nadir value measured on 3 consecutive occasions at least 1 week apart
  • Antiandrogen therapy must have been stopped at least 4 weeks prior to start of trial treatment (6 weeks in the case of bicalutamide or nilutamide)if there was a reduction in serum PSA after this therapy was initiated
  • Baseline serum prostate-specific antigen (PSA)≥10ng/ml
  • Total testosterone <50 ng/dL (<1.7 nmol/L)
  • Adequate hematologic values: neutrophil count ≥1,500/mm3, platelet ≥100,000/mm3, hemoglobin ≥10.0 g/dl
  • Adequate hepatic and renal function: total bilirubin level ≤1.5 x ULN (unless secondary to documented Gilbert's disease); ALT,AST, and creatinine ≤1.5 x ULN
  • Ability to understand and to sign consent for the study

Exclusion Criteria:

  • Prior treatment for prostate cancer with chemotherapy or radioisotopes
  • History of another cancer within the preceding five years (except basal or squamous-cell skin cancer or adequately treated superficial bladder cancer)
  • Known or suspected brain or leptomeningeal metastases
  • Symptomatic peripheral neuropathy of grade 2 or higher
  • Major surgery within 4 weeks of start of trial treatment
  • Radiotherapy to ≥25% of the bone marrow and any radiotherapy within 4 weeks of start of trial treatment
  • Known hypersensitivity to trial treatment or hypersensitivity to any of its components
  • Any concomitant drugs contraindicated for use with the trial treatment
  • Any serious underlying medical condition which could impair the ability of the patient to participate in the trial
  • Any psychological, familial, sociological or other patient related factors that might preclude compliance with the study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748500

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Monique Cardoza       monique.cardoza@uhn.ca   
Principal Investigator: Ian Tannock         
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01748500     History of Changes
Other Study ID Numbers: PANDORA, 12-0388-C
Study First Received: December 10, 2012
Last Updated: January 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
metastatic

Additional relevant MeSH terms:
Genital Diseases, Male
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Pantoprazole
Docetaxel
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014