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

NCT ID: NCT00307294

Last Updated: 2017-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2012-01-31

Brief 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.

Detailed 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.

Conditions

Prostate Cancer

Keywords

Prostate; Androgen; AIPC; Doxil

Study Design

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

Study Groups

thalidomide and doxil

Combination of Thalidomide and Doxil

Group Type: EXPERIMENTAL

Thalidomide

Intervention Type: DRUG

100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg

Doxil

Intervention Type: DRUG

On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Interventions

Thalidomide

100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg

Intervention Type: DRUG

Doxil

On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Intervention Type: DRUG

Other Intervention Names

Thalomid; doxorubicin liposome

Eligibility Criteria

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

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

Sponsors

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gurkamal S Chatta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

05-078

Identifier Type: -

Identifier Source: org_study_id