Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00049608

Purpose

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	Intervention	Phase
Breast Cancer Colorectal Cancer Lung Cancer Pancreatic Cancer	Dietary Supplement: mistletoe extract Drug: gemcitabine hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Lung Cancer Pancreatic Cancer

Drug Information available for: Viscumin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	51
Study Start Date:	July 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049608

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Patrick J. Mansky, MD

National Center for Complementary and Alternative Medicine (NCCAM)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000258130, NCCAM-02-AT-260, NCI-02-AT-0260
Study First Received:	November 12, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00049608 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Antimetabolites
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Pancreatic Neoplasms
Physiological Effects of Drugs
Colonic Diseases
Rectal Diseases
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms

Therapeutic Uses
Gemcitabine
Breast Diseases
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Digestive System Neoplasms
Skin Diseases
Breast Neoplasms
Endocrine System Diseases
Enzyme Inhibitors
Intestinal Diseases
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Intestinal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009