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

NCT ID: NCT01204996

Last Updated: 2012-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-11-30

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

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

CNTO888 + docetaxel 15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks

Group Type: EXPERIMENTAL

CNTO888 + docetaxel

Intervention Type: DRUG

15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks

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

Group Type: EXPERIMENTAL

CNTO888 + gemcitabine

Intervention Type: DRUG

15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle

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

Group Type: EXPERIMENTAL

CNTO888 + Paclitaxel and carboplatin

Intervention Type: DRUG

15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks

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

Group Type: EXPERIMENTAL

CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection

Intervention Type: DRUG

10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

CNTO888 + docetaxel

15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Centocor

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

Detroit, Michigan, United States

Tacoma, Washington, United States

Barcelona, , Spain

Madrid, , Spain

PAU de Sanchinarro, , Spain

Countries

United States; Spain

References

Brana I, Calles A, LoRusso PM, Yee LK, Puchalski TA, Seetharam S, Zhong B, de Boer CJ, Tabernero J, Calvo E. Carlumab, an anti-C-C chemokine ligand 2 monoclonal antibody, in combination with four chemotherapy regimens for the treatment of patients with solid tumors: an open-label, multicenter phase 1b study. Target Oncol. 2015 Mar;10(1):111-23. doi: 10.1007/s11523-014-0320-2. Epub 2014 Jun 15.

Reference Type: DERIVED

PMID: 24928772 (View on PubMed)

Other Identifiers

2009-015541-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNTO888STM1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR016462

Identifier Type: -

Identifier Source: org_study_id