OBJECTIVES:

• Determine the effect of Hypericum perforatum (St. John's Wort) on the pharmacokinetic clearance of docetaxel in patients with unresectable solid tumors.
• Determine the effect of Hypericum perforatum on the production and plasma concentrations of M4-C13-hydroxydocetaxel in these patients.
• Determine the effects of this drug on the pharmacodynamics of docetaxel in these patients.
• Determine the relationship between the effects of this drug on docetaxel metabolic clearance and CYP3A4/CYP3A5 genotype in these patients.
• Determine the relationship between the effect of this drug on docetaxel metabolic clearance and p-glycoprotein genotype in these patients.
• Determine the relationship between the effect of this drug on docetaxel clearance and pregnane receptor genotype in these patients.
• Assess compliance with this drug in these patients.
• Assess the steady state concentrations of hyperforin, one of the putative psychoactive components of Hypericum perforatum, in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients who have not been receiving chronic Hypericum perforatum (St. John's Wort) are assigned to group A, while a cohort of 8 patients who have been receiving chronic Hypericum perforatum are assigned to group B.

• Patients are randomized to 1 of 2 treatment arms.
• Arm I: Patients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15.
• Arm II: Patients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm I.
• Group B (non-randomized group): Patients receive docetaxel as in arm I and continue to receive their chronic regimen of Hypericum perforatum except 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.

PROJECTED ACCRUAL: Approximately 92 patients will be accrued for this study.

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