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

July 11, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase III Randomized Study of Hypericum Perforatum (St. John's Wort) Combined With Docetaxel in Patients With Unresectable Solid Tumors

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Drug: docetaxel
Drug: Hypericum perforatum
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.
Drug: docetaxel
Drug: Hypericum perforatum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Lionel D. Lewis, MD, Norris Cotton Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 6, 2022

Primary Completion

December 6, 2022

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

July 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-60002
  • CDR0000069449 (Registry Identifier: PDQ (Physician Data Query))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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