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

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ClinicalTrials.gov Identifier: NCT00041171
Recruitment Status : Withdrawn (The study was not activated.)
First Posted : January 27, 2003
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE July 8, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 12, 2016
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00041171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
Official Title  ICMJE Phase III Randomized Study of Hypericum Perforatum (St. John's Wort) Combined With Docetaxel in Patients With Unresectable Solid Tumors
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Adult Solid Tumor
  • Breast Cancer
  • Head and Neck Cancer
  • Kidney and Urinary Cancer
  • Male Reproductive Cancer
  • Thorax and Respiratory Cancer
Intervention  ICMJE
  • Drug: Hypericum perforatum
  • Drug: docetaxel
  • Other: placebo
Study Arms  ICMJE
  • Experimental: Arm 1: placebo + docetaxel

    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.

    Interventions:
    • Drug: docetaxel
    • Other: placebo
  • Experimental: Arm 2: Hypericum perforatum + docetaxel

    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.

    Interventions:
    • Drug: Hypericum perforatum
    • Drug: docetaxel
  • Experimental: Arm 3: Hypericum perforatum + docetaxel

    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.

    Interventions:
    • Drug: Hypericum perforatum
    • Drug: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July¬†9,¬†2015)
0
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00041171
Other Study ID Numbers  ICMJE CALGB-60002
CDR0000069449 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Lionel D. Lewis, MD Norris Cotton Cancer Center
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP