Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Gurkamal S Chatta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

January 2012

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Androgen
  • AIPC
  • Doxil
  • Prostatic Neoplasms



Hillman Cancer Center Pittsburg, Pennsylvania  15232