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

Phase 3

Withdrawn

• Conditions: Adult Solid Tumor; Breast Cancer; Head and Neck Cancer; Kidney and Urinary Cancer; Male Reproductive Cancer; Thorax and Respiratory Cancer
• Interventions: Drug: Hypericum perforatum; Drug: docetaxel; Other: placebo

• Registration Number: NCT00041171
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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 Timeline

• Study First Submitted: 2002-07-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: placebo + docetaxel	placebo	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.
Arm 2: Hypericum perforatum + docetaxel	Hypericum perforatum	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.
Arm 3: Hypericum perforatum + docetaxel	Hypericum perforatum	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.
Arm 1: placebo + docetaxel	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.
Arm 2: Hypericum perforatum + docetaxel	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.
Arm 3: Hypericum perforatum + docetaxel	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.