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

NCT00394810 | Completed Phase 2

• 1 other identifier: ME-CLN-006
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 6 month progression free survival

  at time of progression

Study Arms (1)

1

EXPERIMENTAL

Drug: Panzem® NCD

Interventions

Panzem® NCD DRUG

suspension, 100 mg/mL, four times daily continuous dosing

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (pts) must have histologically or cytologically confirmed adenocarcinoma of the prostate.
• 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.
• 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.
• 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).
• Age ≥18 years.
• Life expectancy of greater than 12 weeks.
• Eastern Cooperative Oncology Group \[ECOG\] performance status of 2 or less
• Pts must have near normal organ and marrow function within 2 weeks prior to registration as defined below:
• Granulocytes \> 1500/mm³

You may not qualify if:

• 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.
• 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.
• 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.
• 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).
• Patients must not have any known history of carcinomatous meningitis or brain metastases.
• 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.
• No major surgery within 21 days of starting treatment with Panzem NCD.
• Pts must not receive any investigational agents other than Panzem NCD for the duration of their participation in this trial.

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (4)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Harrison MR, Hahn NM, Pili R, Oh WK, Hammers H, Sweeney C, Kim K, Perlman S, Arnott J, Sidor C, Wilding G, Liu G. A phase II study of 2-methoxyestradiol (2ME2) NanoCrystal(R) dispersion (NCD) in patients with taxane-refractory, metastatic castrate-resistant prostate cancer (CRPC). Invest New Drugs. 2011 Dec;29(6):1465-74. doi: 10.1007/s10637-010-9455-x. Epub 2010 May 25.

  PMID: 20499131 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Glenn Liu, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 30, 2006
• First Posted: November 1, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 25, 2008

Record last verified: 2008-11

Locations

US (4)