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Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer

15. marts 2016 opdateret af: The Methodist Hospital Research Institute

Phase II Study of Patients With Hormone-Naïve Prostate Cancer With a Rising Prostate Specific Antigen: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Thalidomide Plus Docetaxel

The purpose of this study is to assess the relative efficacy and toxicity of combination therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising PSA.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

As more men are being diagnosed and treated for prostate cancer at an early age, the number who experiences a rising level of prostate-specific antigen (PSA) after initial treatment is increasing, affecting approximately 50,000 patients each year.

These three drugs are commercially available. Thalidomide is an angiogenesis inhibitor which blocks the development of new blood vessels. GM-CSF stimulates the body's immune response to fight cancer. Docetaxel is the most active chemotherapeutic agent in the treatment of prostate cancer. GM-CSF and thalidomide have proven activity in suppressing PSA values.

This study design offers an opportunity to add cytotoxic therapy (docetaxel) in combination with an active pathobiologic regimen (GM-CSF plus thalidomide) to eradicate micrometastatic disease, thus potentially offering a significant delay to clinical failure as measured by a rise in PSA or radiographic involvement. Additionally, delays in the use of hormone therapy has the potential to be of significant benefit.

GM-CSF will be administered at a fixed dose 3 days per week by subcutaneous injection for 12 months. Participants will receive a fixed dose of thalidomide orally at bedtime daily without interruption for 12 months. Docetaxel will be administered intravenously over 1 hour on week 1 of every cycle (every 3 weeks) for 18 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • The Methodist Hospital Research Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Diagnosis of adenocarcinoma of the prostate.
  • Failure of local treatments (surgery and/or radiation) as defined by a rising PSA; demonstrated by at least three consecutive rises in PSA by intervals of at least 4 weeks apart with an absolute change of at least 1 ng/mL. If the confirmatory PSA (third PSA) is less than the previous screening PSA value, an additional test for rising PSA will be required to document progression.
  • No clinical or radiographic evidence of disease.
  • The Zubrod performance status 0-1.
  • Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as long as androgen therapy has been completed at least 1 year prior to study entry.
  • Adequate hematologic function: absolute granulocytes ≥ 1500/ul, platelets ≥ 100,000/ul, hemoglobin ≥ 10 gm/100 ml within 4 weeks prior to study entry.
  • Adequate hepatic function: bilirubin ≤ 1.5 mg/dl, liver enzymes ≤ 1.5 ULN within 4 weeks prior to study entry.
  • Adequate renal function: creatinine ≤ 1.5 x ULN within 4 weeks prior to study entry.
  • Patients treated with bisphosphonate therapy before or after study entry are eligible to continue in the study.
  • Negative bone scan within 6 weeks prior to study entry.
  • Negative CT scan or MRI of the abdomen and pelvis within 6 weeks prior to study entry.
  • Negative chest x-ray for metastatic disease within 6 weeks prior to study entry.
  • Patients must sign a written informed consent prior to treatment.

Exclusion Criteria:

  • Serious intercurrent medical illness including symptomatic heart disease within 6 months.
  • Previous or concurrent invasive cancers other than superficial non-melanomatous skin cancer unless disease-free for at least 5 years.
  • Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
  • History of thromboembolic events (deep venous thrombosis, symptomatic cerebrovascular events or pulmonary embolism), history of MI, within the last 12 months.
  • History of bleeding disorders that would contraindicate Coumadin® (warfarin) including: esophageal varices and clotting factor defects

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: A
Combination therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising PSA
Medicin: GM-CSF
fixed dose of 250 mcg/m2, 3 days per week by subcutaneous injection
Andre navne:
  • Leukin
Medicin: thalidomide
Thalidomide by oral administration at a fixed dose of 200 mg. Prophylactic Coumadin® by oral administration at a fixed dose of 2.5 mg to prevent thromboembolic events (DVT and TIA/stroke) during Thalidomide administration. Thalidomide and Coumadin will be given daily at bedtime without interruption.
Andre navne:
  • Thalomid
Medicin: docetaxel
Docetaxel will be administered by intravenous piggyback over 1 hour at 75mg/m² every 3 weeks. Pre-medication for the docetaxel infusion will consist of dexamethasone 8 mg administered orally 12 hours, 3 hours and 1 hour before docetaxel.
Andre navne:
  • Taxotere

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the relative efficacy of the combination of GM-CSF, Thalidomide and Docetaxel in patients with prostate cancer.
Tidsramme: during study (no data currently available)
PI relocated, no data currently available
during study (no data currently available)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Collect data on hormonal responses produced by GM-CSF, Thalidomide and Docetaxel.
Tidsramme: during study (no data currently available)
PI relocated, no data currently available
during study (no data currently available)
Evaluate safety and toxicity of the combination of GM-CSF, Thalidomide and Docetaxel for patients with hormone naïve prostate cancer.
Tidsramme: during study (no data currently available)
PI relocated, no data currently available
during study (no data currently available)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Methodist Hospital Research Institute

Samarbejdspartnere

Bayer

Efterforskere

  • Ledende efterforsker: Robert J Amato, DO, The Methodist Hospital Research Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2006

Primær færdiggørelse (Faktiske)

1. august 2008

Studieafslutning (Faktiske)

1. september 2008

Datoer for studieregistrering

Først indsendt

19. marts 2007

Først indsendt, der opfyldte QC-kriterier

19. marts 2007

Først opslået (Skøn)

21. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HMRI IRB#1006-0153
  • PCa-06-102 (Anden identifikator: Principal Investigator)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner