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

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00041171

Purpose

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.

Condition	Intervention	Phase
Adult Solid Tumor Breast Cancer Head and Neck Cancer Kidney and Urinary Cancer Male Reproductive Cancer Thorax and Respiratory Cancer	Drug: Hypericum perforatum Drug: docetaxel Procedure: cancer prevention intervention Procedure: chemotherapy Procedure: complementary and alternative therapy	Phase III

Genetics Home Reference related topics: bladder cancer breast cancer

MedlinePlus related topics: Breast Cancer Cancer Head and Neck Cancer Lung Cancer Surgery Tonsils and Adenoids

Drug Information available for: Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase III Randomized Study of Hypericum Perforatum (St. John's Wort) Combined With Docetaxel in Patients With Unresectable Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041171

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Lionel D. Lewis, MD

Norris Cotton Cancer Center

More Information

No publications provided

Study ID Numbers:	CDR0000069449, CLB-60002
Study First Received:	July 8, 2002
Last Updated:	January 11, 2007
ClinicalTrials.gov Identifier:	NCT00041171 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

stage IV non-small cell lung cancer
unspecified adult solid tumor, protocol specific
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III verrucous carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity

Study placed in the following topic categories:

Laryngeal Carcinoma
Squamous Cell Carcinoma
Hypopharyngeal Cancer
Docetaxel
Carcinoma, Adenoid Cystic
Lung Neoplasms
Bladder Neoplasm
Papilloma
Salivary Gland Diseases
Breast Diseases
Nasopharyngeal Carcinoma
Skin Diseases
Urinary Bladder Neoplasms
Breast Neoplasms

Carcinoma, Basal Cell
Granuloma
Recurrence
Carcinoma
Carcinoma, Small Cell
Metastatic Squamous Neck Cancer With Occult Primary
Head and Neck Neoplasms
Epidermoid Carcinoma
Non-small Cell Lung Cancer
Adenoid Cystic Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Non-Small-Cell Lung
Prostatic Neoplasms

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Head and Neck Neoplasms
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009