A Study of the Safety and Efficacy of CNTO 888 in Combination With SoC (Standard of Care) Chemotherapy in Patients With Solid Tumors

CNTO 888 is an antibody that works by blocking a protein called CC-chemokine ligand 2 (CCL2). In research studies CCL2, has been shown to increase the growth of new blood vessels which help the tumor to survive. It is hoped that blocking CCL2 may help to control tumor growth.

Patients will receive one of four treatments. A dose of 15 mg/kg CNTO 888 will be administered once every 3 weeks in combination with either docetaxel, gemcitabine, or paclitaxel-carboplatin in Treatment Arms 1, 2, and 3, respectively; and 10 mg/kg CNTO 888 will be administered once every 2 weeks with DOXIL® / Caelyx® (doxorubicin HCl liposome injection) for intravenous infusion once every 4 weeks in Treatment Arm 4. The maximum time that patients will be in the study is one year.

Safety assessments will be conducted throughout the course of the study. Safety assessments include the monitoring of side effects,clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs, and physical examinations. CNTO 888 will be administered IV at 2 different doses (15 mg/kg or 10 mg/kg) dependant on the chemotherapy combination. Combination therapy will be continued until disease progression, unacceptable toxicity, the patient refuses further combination therapy, withdraws consent, or is treated for 1 year

Inclusion criteria

• Documentation of an advanced solid tumor
• No more than 2 previous anticancer therapies
• good performance status
• adequate bone marrow, liver, and renal function / adequate blood test values
• willing to use birth control measures

Exclusion criteria

• No residual toxicities resulting from previous therapy
• no known allergies, hypersensitivity, or intolerance to antibodies or chemotherapies
• clinically significant bleeding or requiring concurrent therapeutic dose of anticoagulation