Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)
This study has been completed.
Sponsor:
University of Pittsburgh
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00307294
First received: March 24, 2006
Last updated: June 20, 2012
Last verified: June 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study 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 ] [ 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 ]
| 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: one
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
Other Names:
|
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
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
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00307294 History of Changes |
| Other Study ID Numbers: | 05-078 |
| Study First Received: | March 24, 2006 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 Genital Diseases, Male Prostatic Diseases Androgens Doxorubicin Thalidomide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013