Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC) - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Ortho Biotech, Inc.
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00307294

Purpose

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® (doxorubicin HCL liposome injection)	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Thalidomide Doxorubicin Doxorubicin hydrochloride Myocet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Response Rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Overall Survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Tolerance/Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	35
Study Start Date:	March 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
one: Experimental 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 Drug: Doxil® (doxorubicin HCL liposome injection) On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307294

Contacts

Contact: Gurkamal S. Chatta, MD

412-648-6466

chattags@upmc.edu

Locations

United States, Pennsylvania
Hillman Cancer Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Gurkamal S Chatta, MD

Sponsors and Collaborators

University of Pittsburgh

Ortho Biotech, Inc.

Investigators

Principal Investigator:

Gurkamal S Chatta, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	University of Pittaburgh Cancer Institute ( Gurkamal Chatta, MD )
Study ID Numbers:	05-078
Study First Received:	March 24, 2006
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00307294 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

Prostate
Androgen
AIPC
Doxil

Study placed in the following topic categories:

Immunologic Factors
Genital Neoplasms, Male
Prostatic Diseases
Thalidomide
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male

Angiogenesis Inhibitors
Hormones
Immunosuppressive Agents
Doxorubicin
Anti-Bacterial Agents
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Anti-Infective Agents
Thalidomide
Prostatic Diseases
Genital Neoplasms, Male
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Antibiotics, Antineoplastic
Hormones
Anti-Bacterial Agents
Neoplasms by Site

Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Genital Diseases, Male
Immunosuppressive Agents
Angiogenesis Inhibitors
Doxorubicin
Pharmacologic Actions
Neoplasms
Prostatic Neoplasms
Androgens
Leprostatic Agents

ClinicalTrials.gov processed this record on May 07, 2009