Efficacy and Pharmacodynamic Study of Panzem® NCD in Patients With Hormone-Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00394810
First received: October 30, 2006
Last updated: November 24, 2008
Last verified: November 2008
  Purpose

This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacokinetics, of Panzem® NCD in patients with metastatic, docetaxel refractory, androgen-independent prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: Panzem® NCD
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Efficacy and Pharmacodynamic Study of 2-Methoxyestradiol Nanocrystal Colloidal Dispersion(Panzem® NCD) in Patients With Taxane-Refractory, Metastatic,Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by CASI Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 6 month progression free survival [ Time Frame: at time of progression ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: November 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Panzem® NCD
suspension, 100 mg/mL, four times daily continuous dosing

  Eligibility

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

Inclusion Criteria:

  1. Patients (pts) must have histologically or cytologically confirmed adenocarcinoma of the prostate.
  2. Pts must have evidence of progressive metastatic disease (e.g., new lesions on bone scan or new/enlarging lesions on computerized tomography [CT] scan) or known metastatic disease and rising PSA, during or after treatment with a taxane-based regimen (as well as any other subsequent non-cytotoxic therapy).

    • Pts with bone metastases only (i.e., lacking soft-tissue disease) must have a PSA level of 10 ng/mL or higher.
    • Pts with soft tissue metastases and/or visceral disease must have either measurable disease (per RECIST criteria) or a PSA level of 10 ng/mL or higher.
    • For pts with stable metastatic disease and rising PSA: two consecutive rises in PSA measurement are necessary, each separated from the previous by a minimum of two weeks. The most recent PSA value must be obtained within 1 week prior to registration.
    • At least 3 PSA values within 6 months of registration (each separated by at least 2 weeks) using the same clinical laboratory needs to be available for calculation of the PSA pre-treatment slope. Only those values obtained after the last treatment date (see inclusion criteria #5 below) will be acceptable.
  3. Pts must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure.

    • Pts who have not undergone bilateral orchiectomy must continue their luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist (e.g. abarelix) while receiving protocol therapy.
    • A serum testosterone level of 50 ng/dL or lower is required to confirm castration status within 4 weeks prior to study entry.
  4. For pts previously treated with flutamide (Eulixin), Nilutamide (Nilandron), or bicalutamide (Casodex): pts must have discontinued flutamide 4 weeks or more prior to registration with continued evidence of progressive disease. For bicalutamide or nilutamide, pts must have discontinued the drug 6 weeks or more prior to registration with evidence of progressive disease.

    • Disease progression following anti-androgen withdrawal needs to be confirmed by a rising PSA after the required 4-6 week washout period (e.g. PSA level higher than the last PSA obtained while on anti-androgen therapy).

  5. Pts must have received only one prior taxane-based regimen for metastatic disease, with evidence of disease progression (inclusion criteria #2) during treatment or within 6 months of treatment discontinuation. Up to one other prior experimental therapy (non-cytotoxic) is permitted. At least 4 weeks or more from previous treatment must have elapsed prior to registration, with evidence for disease progression as outlined in inclusion criteria #2.
  6. Age ≥18 years.
  7. Life expectancy of greater than 12 weeks.
  8. Eastern Cooperative Oncology Group [ECOG] performance status of 2 or less
  9. Pts must have near normal organ and marrow function within 2 weeks prior to registration as defined below:

    • Granulocytes > 1500/mm³
    • Platelet count > 100,000/mm³
    • Bilirubin < 1.5 mg/dL
    • Serum glutamate pyruvate transaminase (ALT) < 2 times the institutional upper limit of normal
    • Creatinine < 1.5 mg/dL or a calculated creatinine clearance > 50 mL/min
  10. Pts with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for 5 years or more (excluding non-melanomatous skin cancers treated with curative intent).
  11. All sites of disease must be evaluated within 4 weeks prior to registration.
  12. Have the ability to understand the requirements of the study, provide written informed consent and authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.

Exclusion Criteria:

  1. The use of bisphosphonates (i.e. pamidronate sodium or zoledronic acid) will be allowed provided that the patient has been receiving that medication for 4 weeks or more with evidence of progressive disease as outlined above.

    • Pts will not be allowed to start bisphosphonate while receiving protocol treatment unless clinically indicated (will need approval of the study principal investigator). Those patients already on a bisphosphonate will need to continue to receive the bisphosphonate as previously scheduled.

  2. Pts must not have had prior radiotherapy within 4 weeks prior to registration. Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope.

    • If a pt requires palliative radiotherapy, two consecutive rises (baseline value must be obtained after completion of radiation treatment) in PSA measurement are necessary, each separated from the previous by a minimum of two weeks.

  3. No concurrent use of estrogen, or estrogen-like agents (i.e. PC-SPES, Saw Palmetto, or other herbal products which may contain phytoestrogens), or any other hormonal therapy (including megastrol acetate, finasteride, ketoconazole, and systemic corticosteroids) is allowed at any time during the study. Prior use of these agents will need to be discontinued 4 weeks or more prior to enrollment. Disease progression needs to be confirmed as outlined in inclusion criteria #2.
  4. Pts with type I insulin-dependent diabetes or poorly-controlled type II insulin-dependent diabetes or a fasting blood glucose of more than 10 mmol/L (200 mg/dL) will be excluded due to difficulty evaluating the tumor metabolic activity using FDG-PET.
  5. Patients must not have active angina pectoris, or known heart disease of New York Heart Association Class III-IV. Patients must not have a history of myocardial infarction within 6 months prior to registration. No history or evidence of ventricular dysrhythmias or other unstable arrythmia is allowed (rate controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint).
  6. Patients must not have any known history of carcinomatous meningitis or brain metastases.
  7. No serious concurrent medical illness or active infection should be present which would jeopardize the ability of the patient to receive the therapy outlined in this protocol with reasonable safety.
  8. No major surgery within 21 days of starting treatment with Panzem NCD.
  9. Pts must not receive any investigational agents other than Panzem NCD for the duration of their participation in this trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394810

Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
Investigators
Principal Investigator: Glenn Liu, MD University of Wisconsin, Madison
  More Information

No publications provided by CASI Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, EntreMed, Inc.
ClinicalTrials.gov Identifier: NCT00394810     History of Changes
Other Study ID Numbers: ME-CLN-006
Study First Received: October 30, 2006
Last Updated: November 24, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014