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

• ClinicalTrials.gov Identifier: NCT00307294
• Recruitment Status: Completed
• First Posted: March 27, 2006
• Results First Posted: February 12, 2016
• Last Update Posted: November 24, 2017
• Sponsor: University of Pittsburgh
• Collaborator: Ortho Biotech, Inc.
• Information provided by (Responsible Party): University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Thalidomide; Drug: Doxil	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: March 2006
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: thalidomide and doxil; Combination of Thalidomide and Doxil	Drug: Thalidomide; 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg; Other Name: Thalomid; Drug: Doxil; On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days; Other Name: doxorubicin liposome

Outcome Measures

Primary Outcome Measures :

1. Response Rate [ Time Frame: 24 weeks ]
   The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.

Secondary Outcome Measures :

1. Best Overall PSA Response [ Time Frame: 4 weeks ]
   PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria.
2. Overall Survival [ Time Frame: 36 months ]
3. Time to Progression [ Time Frame: Up to 18 months ]
   Time from start of treatment until the disease progression per RECIST criteria.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

University of Pittsburgh

Ortho Biotech, Inc.

Investigators

• Principal Investigator: Gurkamal S Chatta, MD; University of Pittsburgh

More Information

• Responsible Party: University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00307294
• Other Study ID Numbers: 05-078
• First Posted: March 27, 2006
• Results First Posted: February 12, 2016
• Last Update Posted: November 24, 2017
• Last Verified: January 2016

Keywords provided by University of Pittsburgh:

Prostate; Androgen; AIPC; Doxil

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Thalidomide; Doxorubicin; Antibiotics, Antineoplastic; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Leprostatic Agents; Anti-Bacterial Agents; Anti-Infective Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors