Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00049608
• Other study ID #: CDR0000258130
• Secondary ID: NCCAM-02-AT-260N
• Status: Terminated
• Phase: Phase 1
• First received: November 12, 2002
• Last updated: June 17, 2013
• Start date: July 2002
• Est. completion date: August 2011

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00044161

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Dietary Supplement:
• mistletoe extract

Drug:
• gemcitabine hydrochloride

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mansky PJ, Wallerstedt DB, Sannes T, et al.: NCCAM/NCI phase I study of mistletoe extract and gemcitabine in patients with advanced solid tumors. [Abstract] J Clin Oncol 28 (Suppl 15): A-2559, 2010.