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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Colorectal Cancer, Lung Cancer, Pancreatic Cancer

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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 OfficeBethesda, Maryland  20892-1182