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Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer

31. juli 2017 opdateret af: Wake Forest University Health Sciences

A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum

RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel together with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the response rate in patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer treated with docetaxel and capecitabine.

Secondary

  • Determine the time to progression in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the quality of life during treatment of these patients.

OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for ≥ 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 1 of each course, and then at completion of study treatment.

After completion of study treatment, patients are followed every 2-3 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1096
        • Wake Forest University Comprehensive 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

18 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Ovarian epithelial adenocarcinoma
    • Fallopian tube cancer
    • Peritoneal cavity cancer
  • Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease)
  • Platinum-resistant disease, defined as 1 of the following:

    • Treatment-free interval < 6 months after platinum-based therapy
    • Disease progression during platinum-based therapy
  • Measurable disease by physical exam, chest x-ray, CT scan, or MRI
  • No brain metastases

PATIENT CHARACTERISTICS:

  • Gynecologic Oncology Group performance status 0-2
  • Life expectancy > 6 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8 g/dL
  • Creatinine clearance ≥ 50 mL/min
  • Bilirubin normal
  • AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria:

    • AST or ALT ≤ 5 times upper limit of normal (ULN) AND AP normal
    • AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
    • AST or ALT normal AND AP ≤ 5 times ULN
  • No peripheral neuropathy > grade 2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No other concurrent malignancy except for curatively treated nonmelanoma skin cancer
  • No prior invasive malignancy < 5 years after curative therapy
  • No serious uncontrolled medical or psychiatric illness that would preclude study participation or limit survival to < 6 months
  • No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 or to fluoropyrimidine therapy or fluorouracil
  • No inability to tolerate oral medication due to bowel obstruction, lack of physical integrity of the upper gastrointestinal tract, inability to swallow, or malabsorption syndrome
  • No serious concurrent infections
  • No clinically significant cardiac disease not well controlled with medication, including any of the following:

    • Congestive heart failure
    • Symptomatic coronary artery disease
    • Symptomatic cardiac arrhythmias
    • Myocardial infarction within the past 12 months

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior docetaxel or capecitabine or other fluoropyrimidine therapy
  • Recovered from prior therapy
  • At least 2 weeks since prior major surgery
  • At least 4 weeks since prior chemotherapy, hormone therapy, or radiotherapy
  • No other concurrent chemotherapeutic agents, biological therapy, radiotherapy, or other investigational agents

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
Eksperimentel: Weekly Docetaxel and Capecitabine
oral capecitabine twice daily on days 1-21
docetaxel IV over 30 minutes on days 1, 8, and 15

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Tumor Response
Tidsramme: 8 weeks
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Progression
Tidsramme: Evaluated every 8 weeks during treatment
Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter
Evaluated every 8 weeks during treatment
Number of Participants With Grade 3 or Higher Toxicity
Tidsramme: Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.
Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
Quality of Life
Tidsramme: Pre-entry, day 1, treatment end
comparison of treatment end to pre entry and day 1 of each treatment cycle.
Pre-entry, day 1, treatment end

Samarbejdspartnere og efterforskere

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

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. januar 2006

Primær færdiggørelse (Faktiske)

1. maj 2008

Studieafslutning (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først indsendt

19. juli 2006

Først indsendt, der opfyldte QC-kriterier

19. juli 2006

Først opslået (Skøn)

20. juli 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2017

Sidst verificeret

1. marts 2017

Mere information

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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