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Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

6. august 2013 opdateret af: Ludwig-Maximilians - University of Munich

A Randomized Phase II/III Trial Comparing Carboplatin-Ifosfamide (IC)-Chemotherapy Vs. IC-Chemotherapy Combined With Extreme Whole Body Hyperthermia In Patients With Recurrence Of Epithelial Ovarian Carcinoma: DOLPHIN-1-STUDY

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy is more effective with or without whole-body hyperthermia therapy in treating gynecologic cancer.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of chemotherapy with or without whole-body hyperthermia in treating patients who have recurrent ovarian epithelial, fallopian tube, or peritoneal cancer.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Compare the time to progressive disease in patients with recurrent ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer treated with carboplatin and ifosfamide with or without whole body hyperthermia.
  • Compare the response rate, duration of response, and survival time of patients treated with these regimens.
  • Compare the effect on the presence of disseminated tumor cells in bone marrow in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Assess quality of life of patients treated with these regimens.

OUTLINE: This is a phase II safety and efficacy study followed by a phase III randomized, open-label, multicenter study.

  • Phase II: Patients receive ifosfamide IV over 1 hour and carboplatin IV over 20 minutes on day 1. Patients also undergo whole body hyperthermia for at least 1 hour on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

  • Phase III (after successful treatment of 15 patients in phase II): Patients are stratified according to disease-free interval (6-12 months vs more than 12 months), measurable disease (bidimensionally measurable vs measurable by other clinical means), and disease recurrence (first recurrence vs second or greater recurrence). Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive ifosfamide, carboplatin, and whole body hyperthermia as in phase II.
    • Arm II: Patients receive ifosfamide and carboplatin as in arm I.
    • In both arms, treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before each course, 4 weeks after the last course, and then every 3 months for 2 years.

Patients are followed at 4 weeks and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for phase II of this study. A total of 226 patients (113 per treatment arm) will be accrued for phase III of this study within 2 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

241

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Holland
      • Amsterdam, Holland, 1105 AZ
        • Rekruttering
        • Academisch Medisch Centrum at University of Amsterdam
        • Kontakt:
  • Tyskland
      • Berlin, Tyskland, D-13353
        • Rekruttering
        • Charite University Hospital - Campus Virchow Klinikum
        • Kontakt:
      • Frankfurt, Tyskland, D-60488
        • Rekruttering
        • Krankenhaus Nordwest
        • Kontakt:
          • Elke Jaeger, MD
          • Telefonnummer: 49-69-7601-3380
      • Hamburg, Tyskland, D-20246
        • Rekruttering
        • University Medical Center Hamburg - Eppendorf
        • Kontakt:
      • Luebeck, Tyskland, D-23538
        • Rekruttering
        • Universitaets - Kinderklinik - Luebeck
        • Kontakt:
      • Trostberg, Tyskland, D-83308
        • Rekruttering
        • Kreiskrankenhaus Trostberg
        • Kontakt:
          • A. Biedermann, MD
          • Telefonnummer: 0862-11-87-5020
  • Ungarn
      • Budapest, Ungarn, 1076
        • Rekruttering
        • Peterfy Korhaz Szulo-Nobeteg Oztaly
        • Kontakt:
          • L. Kornya, MD
          • Telefonnummer: 36-1-322-3450

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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer

    • Recurrent disease (any FIGO stage)
    • Not amenable to curative surgery or radiotherapy alone
  • Failed prior primary platinum-based therapy at least 6 months after therapy discontinuation

  • Measurable lesion by CT scan, MRI, chest x-ray, or sonography

    • Physical examination allowed for documenting lymph node and skin metastases
    • Physical gynecological examination allowed for well-defined palpable tumor lesions
    • Increase in CA 125 without any measurable tumor is not acceptable as indication of recurrence
  • No CNS metastases
  • No tumor of borderline malignancy

PATIENT CHARACTERISTICS:

Age

  • 18 to 65

Performance status

  • ECOG 0-2

Life expectancy

  • At least 24 weeks

Hematopoietic

  • Neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic

  • Not specified

Renal

  • Creatinine clearance at least 60 mL/min
  • No chronic or acute renal failure

Cardiovascular

  • Cardiovascular function sufficient for hyperthermia treatment by stress-ECG
  • No cardiomyopathy with impaired ventricular function
  • No New York Heart Association class III or IV heart disease
  • No cardiac arrhythmias influencing LVEF and requiring medication
  • No myocardial infarction or angina pectoris within the past 6 months
  • No uncontrolled arterial hypertension

Pulmonary

  • Pulmonary function sufficient for hyperthermia treatment by pulmonary function tests

Other

  • No untreated endocrinological disease (e.g., hyperthyroidism or diabetes mellitus)
  • No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
  • No contraindication against hyperthermia treatment (e.g., photodermatosis, history of malignant hyperthermia, or claustrophobia)
  • No hypersensitivity to carboplatin, ifosfamide, or any other study medication
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No concurrent cytotoxic or other antineoplastic therapy

Endocrine therapy

  • Concurrent hormone replacement therapy allowed
  • Concurrent steroid antiemetics allowed

Radiotherapy

  • See Disease Characteristics
  • At least 1 year since prior radiotherapy (tumoricidal dose) of the pelvis
  • Concurrent palliative local radiotherapy for painful (nonprogressive) existing lesion is allowed if other measurable sites are present
  • No concurrent radiotherapy to a second existing lesion

Surgery

  • See Disease Characteristics

Other

  • No prior form of hyperthermic therapy
  • At least 3 weeks since other medications as part of another clinical study
  • At least 3 weeks since prior investigational agents
  • At least 6 weeks since prior betablockers
  • No concurrent photosensitizing drugs
  • No concurrent betablockers
  • No other concurrent anticancer therapy

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
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Toksicitet
Svarprocent
Livskvalitet
Varighed af svar
Overlevelsestid
Tid til progressiv sygdom
Effects on the presence of disseminated tumor cells in bone marrow

Samarbejdspartnere og efterforskere

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

Sponsor

Ludwig-Maximilians - University of Munich

Efterforskere

  • Studiestol: Harald Sommer, MD, Ludwig-Maximilians - University of Munich

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. juni 2000

Datoer for studieregistrering

Først indsendt

6. september 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2013

Sidst verificeret

1. oktober 2002

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LMU-DOLPHIN-1
  • CDR0000256532 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20220

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 .

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