- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00033644
Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
- Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Colorado
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Denver, Colorado, Forente stater, 80010
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Forente stater, 20307-5001
- Walter Reed Army Medical Center
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Illinois
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Chicago, Illinois, Forente stater, 60612-3864
- Rush-Presbyterian-St. Luke's Medical Center
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Iowa
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Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center
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Maryland
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Bethesda, Maryland, Forente stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Massachusetts
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Boston, Massachusetts, Forente stater, 02111
- Tuft-New England Medical Center
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Minnesota
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Rochester, Minnesota, Forente stater, 55905-0001
- Mayo Clinic Cancer Center
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Missouri
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Saint Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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New Jersey
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Camden, New Jersey, Forente stater, 08103-1489
- Cooper University Hospital
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New York
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Stony Brook, New York, Forente stater, 11794-8091
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Forente stater, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Forente stater, 27157-1065
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cincinnati, Ohio, Forente stater, 45267-0526
- Barrett Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Abington, Pennsylvania, Forente stater, 19001-3788
- Abington Memorial Hospital
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Philadelphia, Pennsylvania, Forente stater, 19104-4283
- University of Pennsylvania Cancer Center
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Texas
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Galveston, Texas, Forente stater, 77555-0587
- University of Texas Medical Branch
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Washington
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Tacoma, Washington, Forente stater, 98405
- Tacoma General Hospital
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Oslo, Norge, N-0310
- Norwegian Radium Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed primary leiomyosarcoma (LMS) of the uterus
- Advanced, persistent, or recurrent disease that is refractory to curative therapy or established treatments
At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR
- At least 10 mm by spiral CT scan
- Tumors within a previously irradiated field are designated as non-target lesions
- Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists), including any active phase III protocol for the same population
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
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 no greater than 1.5 times ULN
Other:
- No active infection requiring antibiotics
- No grade 2 or greater sensory or motor neuropathy
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior cytotoxic chemotherapy for LMS of the uterus
Endocrine therapy:
- At least 1 week since prior hormonal therapy for LMS of the uterus
- Concurrent hormone replacement therapy allowed
Radiotherapy:
- See Disease Characteristics
- Recovered from prior recent radiotherapy
Surgery:
- Recovered from prior recent surgery
Other:
- Recovered from other prior recent therapy
- No prior cancer treatment that would preclude study therapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer, bindevev og mykt vev
- Neoplasmer etter histologisk type
- Neoplasmer
- Sarkom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Antineoplastiske midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Doxorubicin
- Liposomal doksorubicin
- Dakarbazin
- Mitomyciner
- Mitomycin
- Sargramostim
Andre studie-ID-numre
- CDR0000069308
- GOG-0087K
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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