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 range
18 Years – 120 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.