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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

December 15, 2011
December 16, 2012
May 2011
May 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01497925 on ClinicalTrials.gov Archive Site
Determine the maximum tolerated dose (MTD) of ADI-PEG 20 with docetaxel [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer
Phase I Trial of ADI-PEG 20 Plus Docetaxel in Advanced Solid Tumors With Emphasis on Castration Resistant Prostate Cancer (CRPC)

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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Solid Tumors
  • Prostate Cancer
Drug: ADI-PEG 20
Dosage: 4.5, 9, 18 and 36 mg/m2. Frequency: weekly.
Other Name: pegylated arginine deiminase
Experimental: ADI-PEG 20
Intervention: Drug: ADI-PEG 20
Kim RH, Coates JM, Bowles TL, McNerney GP, Sutcliffe J, Jung JU, Gandour-Edwards R, Chuang FY, Bold RJ, Kung HJ. Arginine deiminase as a novel therapy for prostate cancer induces autophagy and caspase-independent apoptosis. Cancer Res. 2009 Jan 15;69(2):700-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
39
Not Provided
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: John Bomalaski, M.D. 858-452-6688 ext 114 jbomalaski@polarispharma.com
United States
 
NCT01497925
POLARIS2010-001
No
Polaris Group
Polaris Group
Not Provided
Not Provided
Polaris Group
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP