Clinical trial NCT00049608: Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Colorectal Cancer
Lung Cancer
Pancreatic Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
state: Maryland
Study officials:
affiliation: National Center for Complementary and Integrative Health (NCCIH)
name: Patrick J. Mansky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.