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Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

3. april 2019 oppdatert av: Gynecologic Oncology Group

A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.

Studieoversikt

Detaljert beskrivelse

OBJECTIVES:

Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine, doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free survival, in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma.

Determine the response rate in patients with measurable disease treated with these regimens.

Compare the toxic effects of these regimens in these patients. Compare the complications in patients treated with these regimens. Determine the dose-intensity and cumulative dose delivery for these regimens in these patients.

OUTLINE:

This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery: Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for surgery Stratum B: Suboptimal residual disease without plans for surgery Stratum C: Suboptimal residual disease with plans for surgeryPatients are randomized to 1 of 5 treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues as in arm I. Arm III: Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I. Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Arm V: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months.

PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be accrued for this study within 3.5-5 years.

Studietype

Intervensjonell

Registrering (Faktiske)

4312

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19103
        • Gynecologic Oncology Group

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma
  • The following are ineligible:

    • Germ cell tumors
    • Sex cord-stromal tumors
    • Carcinosarcomas
    • Mixed Mullerian tumors or carcinosarcomas
    • Metastatic carcinomas from other sites to theovary
    • Low malignant potential tumors, including micropapillary serouscarcinomas
    • Mucinous primary peritoneal carcinoma
  • Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy
  • Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
  • Prior breast cancer allowed provided the following are true:

    • Disease-free for more than 5 years
    • No prior cytotoxic chemotherapy for breast cancer
  • Prior or concurrent primary endometrial cancer allowed if the following conditions are met:

    • Stage no greater than IB
    • Less than 3 mm invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • No acute hepatitis
  • Creatinine no greater than 1.5 times ULN
  • No unstable angina
  • No myocardial infarction within the past 6 months
  • No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No greater than grade 1 sensory or motor neuropathy
  • No active infection that requires antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No severe or ongoing gastrointestinal bleeding that requires blood product support
  • See Disease Characteristics
  • Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true:

    • More than 3 years since prior therapy
    • No evidence of recurrent disease
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true:

    • More than 3 years since prior therapy
    • No evidence of recurrent disease
  • See Disease Characteristics
  • No more than 12 weeks since prior surgical resection

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm I
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Gitt IV
Gitt IV
Andre navn:
  • Anzatax
  • AVGIFT
Eksperimentell: Arm II
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Gitt IV
Gitt IV
Andre navn:
  • Anzatax
  • AVGIFT
Gitt IV
Andre navn:
  • dFdCyd
  • dFdC
Eksperimentell: Arm III
Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I.
Gitt IV
Gitt IV
Andre navn:
  • Anzatax
  • AVGIFT
Andre navn:
  • TLC D-99
  • doxorubicin HCl liposom
Eksperimentell: Arm IV
Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy.
Gitt IV
Gitt IV
Andre navn:
  • Anzatax
  • AVGIFT
Gitt IV
Andre navn:
  • Hycamtin
  • SKF S-104864-A
  • TOPO
Eksperimentell: Arm V
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.
Gitt IV
Gitt IV
Andre navn:
  • Anzatax
  • AVGIFT
Gitt IV
Andre navn:
  • dFdCyd
  • dFdC
Å bli operert

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival
Tidsramme: Up to 9 years
Proportion of participants whose overall survival exceeded 5 years.
Up to 9 years
Progression-free Survival
Tidsramme: From the date of enrollment to first progression or death or last contact, if alive and progression free.
Median duration in months of progression free survival.
From the date of enrollment to first progression or death or last contact, if alive and progression free.

Sekundære resultatmål

Resultatmål
Tidsramme
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
Tidsramme: Up to 9 years
Up to 9 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Michael Bookman, Gynecologic Oncology Group

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2001

Primær fullføring (Faktiske)

1. mars 2010

Studiet fullført (Faktiske)

28. januar 2013

Datoer for studieregistrering

Først innsendt

3. mars 2001

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. april 2019

Sist bekreftet

1. mars 2016

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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