S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer
22. januar 2013 opdateret af: Southwest Oncology Group
Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)
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 docetaxel in treating older women who have metastatic breast cancer.
Studieoversigt
Detaljeret beskrivelse
OBJECTIVES:
- Determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel.
- Determine the overall survival, 2-year survival, and response (confirmed and unconfirmed complete and partial) in patients treated with this drug.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in elderly cancer patients.
- Determine the parameters of clinical pharmacology of this drug in elderly patients and in patients under 60 years of age.
- Determine, preliminarily, the genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance in patients treated with this drug.
OUTLINE: Patients are stratified according to age (70 and over vs under 60).
Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: Approximately 80 patients (60 patients age 70 and over and 20 patients under age 60) will be accrued for this study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
27
Fase
- Fase 2
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
- Distant metastatic disease confirmed by histology, cytology, or strong clinical evidence
- Measurable disease
- No known brain or CNS metastases
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 70 and over OR
- Under 60
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Hemoglobin at least 9 g/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT or SGPT no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present)
- Alkaline phosphatase no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present)
Renal:
- Creatinine no greater than ULN
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy for breast cancer
Chemotherapy:
- Prior adjuvant or neoadjuvant chemotherapy allowed
- Prior adjuvant taxanes allowed
- No other concurrent chemotherapy for breast cancer
Endocrine therapy:
- Prior hormonal therapy in the adjuvant setting or for metastatic disease allowed
- No concurrent hormonal therapy for breast cancer
Radiotherapy:
- No concurrent radiotherapy for breast cancer
Surgery:
- Not specified
Other
- No more than 1 prior regimen for advanced, recurrent, or metastatic disease
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: docetaxel
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Study treatment feasibility
Tidsramme: monthly for duration of accrual
|
monthly for duration of accrual
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overall survival
Tidsramme: at weeks 10 and 19, then every 3 months for 3 years
|
at weeks 10 and 19, then every 3 months for 3 years
|
|
Survival at 2 years
Tidsramme: at weeks 10 and 19, then every 3 months for 2 years
|
at weeks 10 and 19, then every 3 months for 2 years
|
|
Response rate (confirmed and unconfirmed complete and partial response)
Tidsramme: at weeks 10 and 19, then every 3 months for 3 years
|
at weeks 10 and 19, then every 3 months for 3 years
|
|
Toxicity and tolerability
Tidsramme: at week 1, then every 3 weeks
|
at week 1, then every 3 weeks
|
|
Feasibility of standardized self-report measures of comorbidity, depression, and functional status
Tidsramme: upon completion of patient accrual
|
upon completion of patient accrual
|
|
Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age
Tidsramme: upon completion of patient accrual
|
upon completion of patient accrual
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Silvana Martino, DO, Saint John's Cancer Institute
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. oktober 2001
Primær færdiggørelse (Faktiske)
1. juni 2007
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
11. oktober 2001
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. januar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000068966
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- S0029 (Anden identifikator: SWOG)
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