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

NCT ID: NCT00394810

Last Updated: 2008-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-11-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Panzem® NCD

Intervention Type: DRUG

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

Interventions

Panzem® NCD

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

Intervention Type: DRUG

Eligibility 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.

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).

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.

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

CASI Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

EntreMed, Inc.

Principal Investigators

Glenn Liu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Indiana University Cancer Center

Indianapolis, Indiana, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20499131 (View on PubMed)

Other Identifiers

ME-CLN-006

Identifier Type: -

Identifier Source: org_study_id