Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

Phase 1TerminatedNCT00049608

National Center for Complementary and Integrative Health (NCCIH)51 enrolled

Overview

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.

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

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

Overview

Conditions

Interventions

Eligibility

Locations (1)