Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

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