- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00307294
Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)
October 20, 2017 updated by: University of Pittsburgh
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
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- Hillman Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: thalidomide and doxil
Combination of Thalidomide and Doxil
|
100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
Other Names:
On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 36 months
|
36 months
|
|
Best Overall PSA Response
Time Frame: 4 weeks
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PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria.
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4 weeks
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Time to Progression
Time Frame: Up to 18 months
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Time from start of treatment until the disease progression per RECIST criteria.
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Up to 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gurkamal S Chatta, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
March 24, 2006
First Submitted That Met QC Criteria
March 24, 2006
First Posted (Estimate)
March 27, 2006
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
October 20, 2017
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Antibiotics, Antineoplastic
- Thalidomide
- Doxorubicin
Other Study ID Numbers
- 05-078
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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