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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)

Tracking Information
First Submitted Date  ICMJE November 12, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date June 19, 2013
Study Start Date  ICMJE July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Pancreatic Cancer
Intervention  ICMJE
  • Dietary Supplement: mistletoe extract
  • Drug: gemcitabine hydrochloride
Study Arms  ICMJE Not Provided
Publications * Mansky PJ, Wallerstedt DB, Sannes TS, Stagl J, Johnson LL, Blackman MR, Grem JL, Swain SM, Monahan BP. NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors. Evid Based Complement Alternat Med. 2013;2013:964592. doi: 10.1155/2013/964592. Epub 2013 Oct 27. Erratum In: Evid Based Complement Alternat Med. 2014;2014:606348.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)		 51
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2011
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00049608
Other Study ID Numbers  ICMJE CDR0000258130
NCCAM-02-AT-260
NCI-02-AT-0260
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Patrick J. Mansky, MD National Center for Complementary and Integrative Health (NCCIH)
PRS Account National Cancer Institute (NCI)
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP