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Phase I Trial of ADI-PEG 20 Plus Docetaxel in Advanced Solid Tumors With Emphasis on Castration Resistant Prostate Cancer (CRPC)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors, Prostate Cancer

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Trial Information

Phase I Trial of ADI-PEG 20 Plus Docetaxel in Advanced Solid Tumors With Emphasis on Castration Resistant Prostate Cancer (CRPC)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events

Outcome Time Frame:

6 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

POLARIS2010-001

NCT ID:

NCT01497925

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Solid Tumors
  • Prostate Cancer
  • Arginine deiminase
  • Arginine
  • Solid tumors
  • Prostate cancer
  • Phase 1 study
  • Prostatic Neoplasms
  • Neoplasms

Name

Location

University of California at DavisSacramento, California  95817