- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00025493
S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: docetaxel
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Study treatment feasibility
Tidsram: monthly for duration of accrual
|
monthly for duration of accrual
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Overall survival
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: upon completion of patient accrual
|
upon completion of patient accrual
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Silvana Martino, DO, Saint John's Cancer Institute
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDR0000068966
- U10CA032102 (U.S.S. NIH-anslag/kontrakt)
- S0029 (Annan identifierare: SWOG)
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