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Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00049608
Recruitment Status : Terminated (Principal investigator [PI] has left institution.)
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2002
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049608


Locations
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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 Integrative Health (NCCIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Patrick J. Mansky, MD National Center for Complementary and Integrative Health (NCCIH)
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00049608    
Obsolete Identifiers: NCT00044161
Other Study ID Numbers: CDR0000258130
NCCAM-02-AT-260
NCI-02-AT-0260
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: April 2007
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:
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Breast Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
 Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs