Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer, Colorectal Cancer, Lung Cancer, Pancreatic Cancer

Intervention / Treatment
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* Dietary Supplement: mistletoe extract
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: mistletoe extract|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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