A Phase I Pharmacokinetics and Pharmacodynamic Study of GTI2040 in Combination With Gemcitabine in Patients With Solid Tumors

Study start date: January 1, 2004

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