Clinical trial · Interventional
Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
Phase III Randomized Study of Hypericum Perforatum (St. John's Wort) Combined With Docetaxel in Patients With Unresectable Solid Tumors
NCT00041171CI-TRIAL-00022962withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was not activated.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Solid Tumor | Adult Solid Neoplasm | ALIAS | 0.90 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Kidney and Urinary Cancer | — | UNRESOLVED | — |
| Male Reproductive Cancer | — | UNRESOLVED | — |
| Thorax and Respiratory Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| Hypericum perforatum | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: placebo + docetaxel
- description
- Patients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15. Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for new primaries and survival only.
- interventionNames
- Drug: docetaxel
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm 2: Hypericum perforatum + docetaxel
- description
- Patients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm 1. Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for new primaries and survival only.
- interventionNames
- Drug: Hypericum perforatum
- Drug: docetaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 palliative radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * At least 6 months since prior Hypericum perforatum (St. John's Wort) * At least 1 week since prior CYP3A enzyme inducers including: * Phenobarbital * Phenytoin * Carbamazepine * Lamotrigine * Rifampin * Rifabutin * Isoniazid * Sulfinpyrazone * Pioglitazone * Anti-HIV drugs such as efavirenz or nevirapine * At least 1 week since prior CYP3A enzyme inhibitors including: * Erythromycin * Clarithromycin * Azithromycin * Roxithromycin * Ketoconazole * Fluconazole * Itraconazole * Metronidazole * Chloramphenicol * Ritonavir * Saquinavir * Indinavir * Nelfinavir mesylate * Delavirdine * Amiodarone * Cyclosporine * Tacrolimus * Sirolimus * Nefazodone * Fluvoxamine * No concurrent CYP3A enzyme inducers * No concurrent CYP3A enzyme inhibitors * No ethanol (especially red wine), grape fruit juice, or seville orange juice (CYP3A enzyme inhibitor) within 3 days before or after receiving docetaxel
References
Publications (0)
Data not yet available
No reference posted for this study.