Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

Criteria

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