NCT00049608

Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

A Phase I Study Of The Effect Of Mistletoe Extract, A Complementary Medicine Botanical, On Pharmacokinetics, Pharmacodynamics And Safety Of Gemcitabine In Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Mistletoe may slow the growth of tumor cells and may be an effective treatment for solid tumors. PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine with mistletoe in treating patients who have advanced solid tumors.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of gemcitabine and mistletoe in patients with advanced solid tumors. * Determine the toxic effects of this regimen in these patients. * Determine the pharmacokinetic effects of gemcitabine with and without mistletoe in these patients. * Determine tumor response in patients treated with this regimen. * Determine the time to neutrophil count recovery in patients treated with this regimen. OUTLINE: This is an open-label, dose-escalation study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and mistletoe subcutaneously daily starting on day 8 of course 1. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of gemcitabine and mistletoe in 2 stages. * Stage I: Cohorts of 3-6 patients receive escalating doses of mistletoe in combination with a constant dose of gemcitabine until the maximum tolerated dose (MTD) of mistletoe is determined. * Stage II: Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination with the MTD of mistletoe as determined in stage I until the MTD of gemcitabine is determined. In both stages, the MTD is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 45-51 patients will be accrued for this study.

Conditions

• Breast Cancer
• Colorectal Cancer
• Lung Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	mistletoe extract
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2002-07-01
• Completion: 2011-08-01
• First posted: 2003-01-27
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States