NCT00041171

Brief 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

First QC Date

July 8, 2002

Last Update Submit

July 11, 2016

Conditions

Adult Solid TumorBreast CancerHead and Neck CancerKidney and Urinary CancerMale Reproductive CancerThorax and Respiratory Cancer

Keywords

stage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancerrecurrent non-small cell lung cancerextensive stage small cell lung cancerrecurrent small cell lung cancerstage III bladder cancerrecurrent bladder cancerstage IV bladder cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerunspecified adult solid tumor, protocol specificuntreated metastatic squamous neck cancer with occult primaryrecurrent metastatic squamous neck cancer with occult primarymetastatic squamous neck cancer with occult primary squamous cell carcinomastage III squamous cell carcinoma of the lip and oral cavitystage III basal cell carcinoma of the lipstage III verrucous carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage IV basal cell carcinoma of the lipstage IV verrucous carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavityrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the liprecurrent verrucous carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent adenoid cystic carcinoma of the oral cavitystage III squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage III inverting papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV inverting papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent inverting papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancer

Study Arms (3)

Arm 1: placebo + docetaxel

EXPERIMENTAL

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.

Drug: docetaxelOther: placebo

Arm 2: Hypericum perforatum + docetaxel

EXPERIMENTAL

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.

Drug: Hypericum perforatumDrug: docetaxel

Arm 3: Hypericum perforatum + docetaxel

EXPERIMENTAL

Patients receive docetaxel as in arm 1 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.

Drug: Hypericum perforatumDrug: docetaxel

Interventions

Hypericum perforatumDRUG
Arm 2: Hypericum perforatum + docetaxelArm 3: Hypericum perforatum + docetaxel
docetaxelDRUG
Arm 1: placebo + docetaxelArm 2: Hypericum perforatum + docetaxelArm 3: Hypericum perforatum + docetaxel
placeboOTHER
Arm 1: placebo + docetaxel

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsHead and Neck NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaUrinary Bladder NeoplasmsProstatic NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland Neoplasms

Interventions

Hypericum extract LI 160Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Lionel D. Lewis, MD

    Norris Cotton Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Last Updated

July 12, 2016

Record last verified: 2016-07