Cancer
Conditions
Keywords
monoclonal antibody, solid tumor, chemotherapy, standard of care
Brief summary
The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens.
Detailed description
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
Interventions
DRUGCNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection
10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks
DRUGCNTO888 + gemcitabine
15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle
DRUGCNTO888 + Paclitaxel and carboplatin
15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks
DRUGCNTO888 + docetaxel
15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks
Sponsors
Centocor, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate the safety of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens. | During treatment and up to 30 days after last study treatment |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics(rate of movement in the body and then the clearance) | during study as specified in the protocol (interim analysis) and at End of Study (1 year) |
| Pharmacodynamics (action of drug on body systems) | during study as specified in the protocol (interim analysis) and at End of Study (1 year) |
Countries
Spain, United States
Outcome results
None listed