Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00049608

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

109

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Colorectal Cancer Lung Cancer Pancreatic Cancer	Dietary Supplement: mistletoe extract Drug: gemcitabine hydrochloride	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

51 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2002

Actual Study Completion Date :

Aug 1, 2011

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic, recurrent, or unresectable locally advanced solid tumor, including one of the following:
Breast or colorectal cancer that has failed first-line chemotherapy
Non-small cell lung cancer
Pancreatic Cancer
No CNS metastases
Hormone receptor status:
Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Male or female

Menopausal status

Not specified

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 2.0 mg/dL
No clinically significant hepatic dysfunction

Renal

Creatinine no greater than 2.5 mg/dL
No clinically significant renal dysfunction

Other

Not pregnant or nursing
Negative pregnancy test
HIV negative
No clinically significant unrelated illness (e.g., serious infection or organ dysfunction) that would preclude study tolerance