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
18 Years
N/A
Both
Breast Cancer, Colorectal Cancer, Lung Cancer, Pancreatic Cancer
Trial Information
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
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.
Inclusion Criteria
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior mistletoe
Chemotherapy
- See Disease Characteristics
- No prior gemcitabine
- More than 30 days since prior chemotherapy and recovered
Endocrine therapy
- More than 30 days since prior glucocorticosteroid therapy
Radiotherapy
- Recovered from prior radiotherapy
Surgery
- Recovered from prior surgery
Other
- At least 30 days since prior investigational agents
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Patrick J. Mansky, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Center for Complementary and Alternative Medicine (NCCAM)
Authority:
United States: Federal Government
Study ID:
CDR0000258130
NCT ID:
NCT00049608
Start Date:
July 2002
Completion Date:
August 2011
Related Keywords:
- Breast Cancer
- Colorectal Cancer
- Lung Cancer
- Pancreatic Cancer
- male breast cancer
- recurrent breast cancer
- recurrent colon cancer
- recurrent non-small cell lung cancer
- recurrent pancreatic cancer
- recurrent rectal cancer
- stage III colon cancer
- stage III pancreatic cancer
- stage III rectal cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- stage IV colon cancer
- stage IV non-small cell lung cancer
- stage IV rectal cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV pancreatic cancer
- Breast Neoplasms
- Colorectal Neoplasms
- Lung Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland 20892-1182 |
