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Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer

10. april 2013 opdateret af: Gynecologic Oncology Group

Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have recurrent ovarian epithelial or primary peritoneal cavity cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: capecitabin

Detaljeret beskrivelse

OBJECTIVES:

Determine the antitumor activity of capecitabine in patients with recurrent, platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer.
Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily for 14 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 6-12 months.

Undersøgelsestype

Interventionel

Fase

Fase 2

Kontakter og lokationer

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

Studiesteder

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Center - Calgary
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
- California
  - Los Angeles, California, Forenede Stater, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, Forenede Stater, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Orange, California, Forenede Stater, 92868
    - Chao Family Comprehensive Cancer Center
- Colorado
  - Denver, Colorado, Forenede Stater, 80010
    - University of Colorado Cancer Center
- Florida
  - Tampa, Florida, Forenede Stater, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
- Illinois
  - Chicago, Illinois, Forenede Stater, 60612
    - Rush-Presbyterian-St. Luke's Medical Center
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46202-5289
    - Indiana University Cancer Center
- Iowa
  - Iowa City, Iowa, Forenede Stater, 52242-1009
    - Holden Comprehensive Cancer Center at the University of Iowa
- Maryland
  - Bethesda, Maryland, Forenede Stater, 20892
    - Radiation Oncology Branch
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02111
    - Tufts University School of Medicine
  - Worcester, Massachusetts, Forenede Stater, 01655
    - University of Massachusetts Memorial Medical Center
- Minnesota
  - Minneapolis, Minnesota, Forenede Stater, 55455
    - University of Minnesota Cancer Center
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Cancer Center
- Missouri
  - Columbia, Missouri, Forenede Stater, 65203
    - Ellis Fischel Cancer Center - Columbia
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Washington University School of Medicine
- New Jersey
  - Camden, New Jersey, Forenede Stater, 08103
    - Cooper Hospital/University Medical Center
- New York
  - Brooklyn, New York, Forenede Stater, 11203
    - State University of New York Health Science Center at Brooklyn
  - New York, New York, Forenede Stater, 10021
    - Memorial Sloan-Kettering Cancer Center
  - Stony Brook, New York, Forenede Stater, 11790-7775
    - State University of New York Health Sciences Center - Stony Brook
- North Carolina
  - Chapel Hill, North Carolina, Forenede Stater, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Durham, North Carolina, Forenede Stater, 27710
    - Duke Comprehensive Cancer Center
  - Winston-Salem, North Carolina, Forenede Stater, 27157-1082
    - Comprehensive Cancer Center at Wake Forest University
- Ohio
  - Cleveland, Ohio, Forenede Stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, Forenede Stater, 43210-1240
    - Arthur G. James Cancer Hospital - Ohio State University
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73190
    - University of Oklahoma College of Medicine
- Pennsylvania
  - Abington, Pennsylvania, Forenede Stater, 19001
    - Abington Memorial Hospital
  - Hershey, Pennsylvania, Forenede Stater, 17033
    - Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Texas
  - Houston, Texas, Forenede Stater, 77030-4009
    - University of Texas - MD 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

DISEASE CHARACTERISTICS:

Histologically proven recurrent ovarian epithelial or primary peritoneal cavity cancer
Measurable disease
- At least 1 unidimensionally measurable lesion
- Ascites and pleural effusions are not considered measurable disease
Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound
- Treatment-free interval of 6-12 months after response to platinum therapy
Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

GOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least lower limit of normal

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN

Renal:

Creatinine clearance at least 50 mL/min

Other:

Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No neuropathy (sensory and motor) greater than grade 1
No other malignancy within the past 5 years except nonmelanoma skin cancer
No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 3 weeks since prior biologic or immunologic therapy
No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

See Disease Characteristics
If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed
No prior capecitabine or fluorouracil
No prior chemotherapy for recurrent or persistent disease, including pretreatment with initial chemotherapy regimens
Recovered from prior chemotherapy

Endocrine therapy:

At least 1 week since prior hormonal therapy directed at malignant tumor
Concurrent continuation of hormone replacement therapy allowed

Radiotherapy:

At least 3 weeks since prior radiotherapy and recovered
No prior radiotherapy to site(s) of measurable disease
No prior radiotherapy to more than 25% of bone marrow

Surgery:

Recovered from prior surgery

Other:

No prior cancer treatment that would preclude study therapy
No concurrent amifostine or other protective reagents

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

Samarbejdspartnere og efterforskere

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

Sponsor

Gynecologic Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Studiestol: Agustin Garcia, MD, University of Southern California

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.

Generelle publikationer

Garcia AA, Blessing JA, Lenz HJ, Darcy KM, Mannel RS, Miller DS, Husseinzadeh N; Gynecologic Oncology Group. Phase II clinical trial of capecitabine in ovarian carcinoma recurrent 6-12 months after completion of primary chemotherapy, with exploratory TS, DPD, and TP correlates: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Mar;96(3):810-7. doi: 10.1016/j.ygyno.2004.11.037.

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. marts 2001

Primær færdiggørelse (Faktiske)

1. juli 2005

Datoer for studieregistrering

Først indsendt

6. december 2000

Først indsendt, der opfyldte QC-kriterier

16. marts 2004

Først opslået (Skøn)

17. marts 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2013

Sidst verificeret

1. november 2005

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000068330
GOG-0146L

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 .