Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Su… (NCT00041171) | Clinical Trial Compass
WithdrawnPhase 3
Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
Stopped: The study was not activated.
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Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. St. John's wort may interfere with the effectiveness of chemotherapy. It is not yet known if chemotherapy is more effective with or without St. John's Wort in treating solid tumors.
PURPOSE: Randomized phase III trial to compare the effectiveness of docetaxel with or without St. John's wort in treating patients who have solid tumors that cannot be removed by surgery.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed unresectable solid tumor, including, but not limited to, the following:
* Lung cancer
* Breast cancer
* Head and neck cancer
* Bladder cancer
* Prostate cancer
* Must be suitable for treatment with single-agent docetaxel
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Male or female
Menopausal status:
* Not specified
Performance status:
* CTC 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than upper limit of normal (ULN)
* Alkaline phosphatase less than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
* BUN no greater than 1.5 times ULN
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior bone marrow transplantation
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No prior docetaxel
* No more than 2 prior chemotherapy regimens
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal agents except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes)
Radiotherapy:
* At least 3 weeks since prior radiotherapy
* No concurrent palliativ…