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PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer

1. august 2012 opdateret af: M.D. Anderson Cancer Center

A Phase I/II Study to Evaluate the Optimum Dose of Pegylated-Interferon (PEG INTRON) in Patients With Platinum Resistant Ovarian, Peritoneal or Fallopian Tube Cancer

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the optimum biologic dose of PEG-interferon alfa-2b in patients with platinum-resistant ovarian epithelial, peritoneal, or fallopian tube cancer.
  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 different treatment arms.

  • Arm I: Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
  • Arm II: Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
  • Arm III: Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.

In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for at least 28 days after study treatment.

PROJECTED ACCRUAL: A maximum of 75 patients will be accrued for this study within 19 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • M D Anderson Cancer Center

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Women with platinum-resistant epithelial ovarian, fallopian tube or peritoneal cancer whose tumor test positive for IL-8 (>31.0 pg/ml), bFGF >7.0 pg/ml), or VEGF (>700 pg/ml). Resistance is defined as:

    1. Progression of disease during platinum chemotherapy, or
    2. Progression of disease within 6 months of completing platinum chemotherapy
    3. Failure to achieve a complete response, with persistent macroscopic disease, after 6 cycles of chemotherapy, if the last two cycles had no measurable change in disease status
  2. Patients with a known hypersensitivity to platinum compounds who have failed a desensitization regimen, or who are not good candidates for desensitization are eligible.
  3. Patients are limited to 4 prior chemotherapy regimens (all platinum and taxane regimens to be counted as one).
  4. Patients must have measurable disease.
  5. Women of any racial and ethnic group.
  6. Zubrod performance status < 2.
  7. Expected survival of > 12 weeks.
  8. Patients must have adequate hepatic, renal, and bone marrow function, defined as serum creatinine < 2 mg/dl (estimated creatinine clearance 50 ml/min); total bilirubin < 2.0 X the upper limit of normal (ULN); alanine aminotransferase (ALT) < 2X ULN; fasting triglycerides < 800 mg/dL; white blood count (WBC) > 3,000/mm3 ; absolute neutrophil count (ANC) > 1,500/mm3; platelets > 100,000/mm3, hemoglobin > 9 g/dl.
  9. At least three weeks must have elapsed from completion of chemotherapy.
  10. Patient agrees not to use complementary alternative medications (e.g., shark cartilage).
  11. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the hospital. The only approved consent is appended to this protocol.

Exclusion Criteria:

  1. Patients with borderline, low grade or low malignant potential tumors are not eligible.
  2. Patients who are pregnant or lactating.
  3. Concurrent chemotherapy, radiation therapy or surgery.
  4. Concurrent, uncontrolled, medical or psychiatric disorders.
  5. Patients with a known hypersensitivity to interferon.
  6. Patients with severe cardiovascular disease (i.e. arrhythmias requiring chronic treatment or congestive heart failure) (NYHA classification III or IV).
  7. Patients who have had interferon within the last 6 months.
  8. Patients with overt psychosis or mental disability or otherwise incompetent to give informed consent.
  9. Patients with a known autoimmune disorder.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PEG-interferon alfa-2b
Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
Starting dose 1.0 mg/kg/week given subcutaneously
Andre navne:
  • PEG-intron

Biological/Vaccine: PEG-interferon alfa-2b

Dose 1.5 mg/kg/week given subcutaneously

EG-Intron

Andre navne:
  • PEG-intron
Eksperimentel: Arm II
Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.

Biological/Vaccine: PEG-interferon alfa-2b

Dose 1.25 mg/kg/week given subcutaneously

Andre navne:
  • PEG-intron
Eksperimentel: Arm III
Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
Starting dose 1.0 mg/kg/week given subcutaneously
Andre navne:
  • PEG-intron

Biological/Vaccine: PEG-interferon alfa-2b

Dose 1.5 mg/kg/week given subcutaneously

EG-Intron

Andre navne:
  • PEG-intron

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Optimal Biologic Dose at 8 weeks
Tidsramme: 8 weeks
Optimum biologic dose of PEG Intron in patients with platinum-resistant ovarian, fallopian tube or peritoneal cancer whose tumors test positive for IL-8, BFGF, or VEGF.
8 weeks
Tumor Response
Tidsramme: Every 2 -3 cycles (8 - 12 weeks)
Each patient tumor response scored as either complete/partial response (CR/PR), stable disease (SD), or failure (F) at 8 weeks after initial treatment.
Every 2 -3 cycles (8 - 12 weeks)

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Studiestol: Judith K. Wolf, MD, M.D. Anderson Cancer Center
  • Studiestol: Pedro T. Ramirez, MD, M.D. Anderson Cancer Center
  • Studiestol: Diane C. Bodurka, MD, M.D. Anderson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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. juli 2002

Primær færdiggørelse (Faktiske)

1. november 2005

Studieafslutning (Faktiske)

1. april 2007

Datoer for studieregistrering

Først indsendt

10. juni 2004

Først indsendt, der opfyldte QC-kriterier

10. juni 2004

Først opslået (Skøn)

11. juni 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2012

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ID02-115
  • P30CA016672 (U.S. NIH-bevilling/kontrakt)
  • P50CA083639 (U.S. NIH-bevilling/kontrakt)
  • MDA-ID-02115 (Anden identifikator: UT MD Anderson Cancer Center)
  • CDR0000368964 (Registry Identifier: NCI PDQ)

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 .

Kliniske forsøg med Livmoderhalskræft

Kliniske forsøg med PEG-interferon alfa-2b

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