Herbal Therapy in Treating Women With Metastatic Breast Cancer
Atslēgvārdi
Abstrakts
Apraksts
OBJECTIVES:
- Determine the efficacy of Scutellaria barbata (Chinese herbal extract) in terms of tumor response in women with metastatic breast cancer.
- Determine the safety and toxicity of this therapy in these patients.
- Determine the feasibility of this therapy in these patients.
- Determine the time to progression, overall survival, and resource utilization of patients treated with this therapy.
- Determine the quality of life of patients treated with this therapy.
- Determine the bioavailability and pharmacokinetics of this therapy in these patients.
OUTLINE: Patients receive oral Scutellaria barbata (Chinese herbal extract) twice daily for 12 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Datumi
| Pēdējoreiz pārbaudīts: | 08/31/2012 |
| Pirmais iesniegtais: | 01/03/2002 |
| Paredzētā reģistrācija iesniegta: | 01/25/2003 |
| Pirmais izlikts: | 01/26/2003 |
| Pēdējais atjauninājums iesniegts: | 09/12/2012 |
| Pēdējā atjaunināšana ievietota: | 09/16/2012 |
| Faktiskais studiju sākuma datums: | 07/31/2001 |
| Paredzamais primārās pabeigšanas datums: | 03/31/2006 |
| Paredzamais pētījuma pabeigšanas datums: | 03/31/2006 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Drug: herba scutellaria barbata
Other: herba scutellaria Barbatae (HSB)
Fāze
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | Female |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer (may include original primary cancer diagnosis) - Measurable disease - Metastatic involvement with minimal or no symptoms - Solitary metastases require histological confirmation - No extensive liver involvement (more than 50% of liver parenchyma) - No lymphangitic pulmonary involvement - CNS involvement or spinal cord compression allowed if stabilized by therapy for more than 3 months - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-1 Life expectancy: - More than 6 months Hematopoietic: - WBC at least 2,500/mm^3 - Platelet count at least 75,000/mm^3 Hepatic: - See Disease Characteristics - Bilirubin no greater than 1.7 mg/dL Renal: - Creatinine no greater than 2.0 mg/dL Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No history of multiple or severe food or medicine allergies PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 week since prior biologic therapy - No concurrent anticancer biologic therapy Chemotherapy: - At least 1 week since prior chemotherapy - No concurrent anticancer chemotherapy Endocrine therapy: - At least 1 week since prior hormonal therapy - No concurrent anticancer hormonal therapy Radiotherapy: - Not specified Surgery: - Not specified Other: - Recovered from prior anticancer therapy - At least 1 week since prior investigational agents - At least 1 week since prior herbal medications - No other concurrent anticancer therapy - No other concurrent investigational agents - Concurrent pamidronate allowed - Concurrent acupuncture or other nonherbal therapy allowed - Concurrent nutritional vitamin supplementation (up to 5 times recommended daily allowance) allowed |
