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

NCT00307294 | Completed Phase 2 Results DMC

• 1 other identifier: 05-078
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate; Androgen; AIPC; Doxil

Outcome Measures

Primary Outcomes (1)

• Response Rate

  The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.

  24 weeks

Secondary Outcomes (3)

• Best Overall PSA Response

  4 weeks

• Overall Survival

  36 months

• Time to Progression

  Up to 18 months

Study Arms (1)

thalidomide and doxil

EXPERIMENTAL

Combination of Thalidomide and Doxil

Drug: Thalidomide; Drug: Doxil

Interventions

Thalidomide DRUG

100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg

Also known as: Thalomid

thalidomide and doxil

Doxil DRUG

On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Also known as: doxorubicin liposome

thalidomide and doxil

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with unstable angina, uncompensated CHF, a history of an MI, PE or DVT within the last 3 months

Sponsors & Collaborators

• University of Pittsburgh: lead
• Ortho Biotech, Inc.: collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Thalidomide; liposomal doxorubicin; Doxorubicin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Rita Johnson RN BSN CCRC
• Organization: University of Pittsburgh

johnsonr1@upmc.edu

412-647-8571

Study Officials

• Gurkamal S Chatta, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 27, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 24, 2017
• Results First Posted: February 12, 2016

Record last verified: 2016-01

Locations

US (1)