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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01204996
First Posted: September 20, 2010
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centocor, Inc.
  Purpose
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.

Condition Intervention Phase
Cancer Drug: CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection Drug: CNTO888 + gemcitabine Drug: CNTO888 + Paclitaxel and carboplatin Drug: CNTO888 + docetaxel Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Phase 1b Study of CNTO 888 (an Anti-CCL 2 Monoclonal Antibody) in Combination With Chemotherapies for the Treatment of Subjects With Solid Tumors

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: During treatment and up to 30 days after last study treatment ]

Secondary Outcome Measures:
  • Pharmacokinetics(rate of movement in the body and then the clearance) [ Time Frame: during study as specified in the protocol (interim analysis) and at End of Study (1 year) ]
  • Pharmacodynamics (action of drug on body systems) [ Time Frame: during study as specified in the protocol (interim analysis) and at End of Study (1 year) ]

Enrollment: 53
Study Start Date: May 2010
Study Completion Date: November 2011
Arms Assigned Interventions
Experimental: 1
CNTO888 + docetaxel 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks
Drug: CNTO888 + docetaxel
15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks
Experimental: 2
CNTO888 + 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
Drug: CNTO888 + 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
Experimental: 3
CNTO888 + 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
Drug: CNTO888 + 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
Experimental: 4
CNTO888+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
Drug: CNTO888+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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204996


Locations
United States, Michigan
Detroit, Michigan, United States
United States, Washington
Tacoma, Washington, United States
Spain
Barcelona, Spain
Madrid, Spain
Sanchinarro, Spain
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr. Director, Clinical Leader, Centocor
ClinicalTrials.gov Identifier: NCT01204996     History of Changes
Other Study ID Numbers: CR016462
2009-015541-23 ( EudraCT Number )
CNTO888STM1002 ( Other Identifier: Centocor )
First Submitted: September 16, 2010
First Posted: September 20, 2010
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Centocor, Inc.:
monoclonal antibody
solid tumor
chemotherapy
standard of care

Additional relevant MeSH terms:
Paclitaxel
Docetaxel
Gemcitabine
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Carboplatin
Doxorubicin
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors