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Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer

This study is currently recruiting participants.
Verified December 2012 by Polaris Group
Sponsor:
Information provided by (Responsible Party):
Polaris Group
ClinicalTrials.gov Identifier:
NCT01497925
First received: December 15, 2011
Last updated: December 16, 2012
Last verified: December 2012
History of Changes
  Purpose

This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize that the combination will result in greater tumor cytotoxicity with an acceptable toxicity profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20 and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that this will be particularly relevant in CRPC.


Condition Intervention Phase
Solid Tumors
Prostate Cancer
 Drug: ADI-PEG 20
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of ADI-PEG 20 Plus Docetaxel in Advanced Solid Tumors With Emphasis on Castration Resistant Prostate Cancer (CRPC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Polaris Group:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Efficacy, as determined by objective response measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the maximum tolerated dose (MTD) of ADI-PEG 20 with docetaxel [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: May 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADI-PEG 20 Drug: ADI-PEG 20
Dosage: 4.5, 9, 18 and 36 mg/m2. Frequency: weekly.
Other Name: pegylated arginine deiminase

  Eligibility

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

Inclusion Criteria:

  • For the phase I portion patients must have cytologically or histologically proven advanced malignant solid tumors, with emphasis on castrate resistant prostate cancer. For the expansion phase, patients must have castrate resistant prostate cancer.
  • 18 years of age or older.
  • Zubrod (ECOG) performance status of 0-2.
  • Estimated survival of at least 3 months.
  • Any prior chemotherapy must have been completed at least 4 weeks prior to start of treatment. Prior radiation must have been completed at least 2 weeks prior to start of therapy.
  • Radiographs (Xrays, CT scans, etc.) to follow disease response or progression must have been completed within 28 days prior to registration.
  • Adequate renal function: calculated creatinine clearance of > 45 ml/min.
  • Adequate liver functions: AST and ALT < 2.5 X upper limit of normal, and bilirubin < upper limit of normal.
  • Adequate bone marrow function: Platelets >100,000 cells/mm3 and ANC > 1,500 cells/mm3.
  • Must not have ≥ Grade 2 symptomatic sensory neuropathy.
  • Must not have a history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Clinically significant concurrent illness.
  • Currently enrolled in a different clinical study.
  • History of allergy or hypersensitivity to the study drug or a taxane.
  • Prior therapy with ADI-PEG 20 or docetaxel.
  • Allergy to pegylated compounds.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497925

Contacts
Contact: John Bomalaski, M.D. 858-452-6688 ext 114 jbomalaski@polarispharma.com

Locations
United States, California
University of California at Davis Recruiting
Sacramento, California, United States, 95817
Contact: Corine Turrell     916-734-3089        
Contact: Tai Akande     (916) 734-0188     Taiwo.Akande@ucdmc.ucdavis.edu    
Principal Investigator: Primo N. Lara, Jr., M.D,            
Sponsors and Collaborators
Polaris Group
  More Information

Publications:

Responsible Party: Polaris Group
ClinicalTrials.gov Identifier: NCT01497925     History of Changes
Other Study ID Numbers: POLARIS2010-001
Study First Received: December 15, 2011
Last Updated: December 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Polaris Group:
Arginine deiminase
Arginine
Solid tumors
Prostate cancer
Phase 1 study

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
 Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013