Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)

Prostate Cancer Clinical Trial

Official title:

Phase II Trial of Thalidomide and Doxil® (Doxorubicin HCL Liposome Injection) in Patients With Androgen Independent Prostate Cancer (AIPC) With a Rising PSA While on Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307294
• Other study ID #: 05-078
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2006
• Last updated: October 20, 2017
• Start date: March 2006
• Est. completion date: January 2012

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease 2) To evaluate overall survival for this combination.

Description:

This is an open label, Phase II trial of thalidomide and Doxil in patients with androgen independent prostate cancer whom have a rising PSA while on chemotherapy. The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease (If measurable soft tissue lesions are present on radiological or clinical exam) ; 2) To evaluate overall survival for this combination. There will be between 18 and 35 subjects at least 18 years of age enrolled on this single site study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate.

• Confirmed androgen independent prostate cancer with evidence of rising PSA (two successive increases in PSA, at least 4 weeks apart) while on chemotherapy. If the PSA is less than 5, the increase in PSA must be at least 50%. Must also have castrate testosterone levels (<50 ng/ml)

• Patients could not have received more than 2 previous chemotherapy regimens.

• No anthracyclines within the past 6 months.

• No prior single agent thalidomide in the last 12 months. No prior cytotoxic chemotherapy + thalidomide given in conjunction

• Age > 18 years of age

• Performance status ECOG 0-2

• Peripheral neuropathy must be < grade 1

• Must have adequate hematologic, hepatic and renal function

• Men of reproductive potential must be willing to consent to using effective contraception while on treatment and for at least 4 weeks thereafter

• Patients must have left ventricular ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring

• Must have been off an anti-androgen for at least 4-6 weeks (Flutamide and Bicalutamide respectively) and documented as having a rising PSA

• Measurable or evaluable disease (PSA elevation will constitute evaluable disease). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques CT scan or as >10 mm with spiral CT scan. See section 6.B for the evaluation of measurable disease

• Life expectancy of greater than 3 months

• Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program

• Ability to understand and sign written informed consent approved by the Institutional Review Board [IRB/Ethics Committee], which will be obtained prior to study entry.

Exclusion Criteria:

• Patients with unstable angina, uncompensated CHF, a history of an MI, PE or DVT within the last 3 months

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Thalidomide
100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
• Doxil
On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Locations

Country	Name	City	State
United States	Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Ortho Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.	24 weeks
Secondary	Best Overall PSA Response	PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria.	4 weeks
Secondary	Overall Survival		36 months
Secondary	Time to Progression	Time from start of treatment until the disease progression per RECIST criteria.	Up to 18 months