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

This study has been completed.
Ortho Biotech, Inc.
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: March 24, 2006
Last updated: January 14, 2016
Last verified: January 2016
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 Intervention Phase
Prostate Cancer
Drug: Thalidomide
Drug: Doxil
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Clinical Response Rate [ Time Frame: 4 weeks ]
  • Overall Survival [ Time Frame: 36 months ]
  • Tolerance/Safety [ Time Frame: 4 weeks ]

Enrollment: 40
Study Start Date: March 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
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Please refer to this study by its identifier: NCT00307294

United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Ortho Biotech, Inc.
Principal Investigator: Gurkamal S Chatta, MD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh Identifier: NCT00307294     History of Changes
Other Study ID Numbers: 05-078
Study First Received: March 24, 2006
Results First Received: January 14, 2016
Last Updated: January 14, 2016

Keywords provided by University of Pittsburgh:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors processed this record on May 25, 2017