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.

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