GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors

Inclusion Criteria

• •Histologically or cytologically confirmed solid tumor
• •* Metastatic or unresectable disease for which standard curative or palliative measures do not exist or are no longer effective
• •Measurable or evaluable disease
• •No known active or progressive brain metastases or primary brain tumors
• •Performance status - ECOG 0-2
• •Performance status - Karnofsky 60-100%
• •More than 12 weeks
• •Hemoglobin \> 9 g/dL
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Bilirubin ≤ 2 times upper limit of normal (ULN)
• •AST and ALT ≤ 3 times ULN (5 times ULN if hepatic metastases are present)
• •Creatinine ≤ 2.0 mg/dL
• •Creatinine clearance ≥ 50 mL/min
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
• •No ongoing or active infection
• •No psychiatric illness or social situation that would preclude study compliance
• •No other condition (e.g., dementia or developmental delay) that would preclude giving informed consent
• •No other concurrent uncontrolled illness that would preclude study participation
• •Prior biologic therapy allowed
• •No concurrent biologic therapy
• •No concurrent immunotherapy
• •No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)
• •Prior gemcitabine allowed
• •Prior investigational chemotherapy allowed
• •At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, carmustine, or nitrosoureas) and recovered
• •No other concurrent chemotherapy
• •Concurrent hormonal therapy (e.g., luteinizing hormone-releasing hormone agonists) for prostate cancer is allowed
• •At least 4 weeks since prior radiotherapy and recovered
• •No prior radiotherapy to more than 25% of bone marrow
• •No concurrent radiotherapy
• •Recovered from prior surgery
• •No other concurrent investigational therapy
• •No other concurrent anticancer therapy
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No concurrent long-term oral anticoagulation therapy (e.g., warfarin)
• •* Prophylactic warfarin to maintain central venous access patency allowed