Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma

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.
 
ClinicalTrials.gov Identifier: NCT01105390
Recruitment Status : Withdrawn (withdrawn)
First Posted : April 16, 2010
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 15, 2010
First Posted Date  ICMJE April 16, 2010
Last Update Posted Date August 2, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
Progression-free survival [ Time Frame: From registration to clinical evidence of disease progression or death without progression, assessed up to 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2010)
Progression-free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
Toxicity defined as a grade 4 hemorrhagic event or a grade 5 event [ Time Frame: Up to 30 days after completion of study treatment ]
Graded using the NCI CTCAE.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2010)
  • Toxicity
  • Response rate
  • Overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma
Official Title  ICMJE A Phase II Trial of AMG 102 in Combination With Pemetrexed and Cisplatin in Patients With Malignant Pleural Mesothelioma
Brief Summary This phase II trial is studying how well giving AMG 102 together with pemetrexed disodium and cisplatin works in treating patients with malignant pleural mesothelioma. Monoclonal antibodies, such as AMG 102, can block tumor growth in different ways. Some block the ability of tumor cells to grow or spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AMG 102 together with pemetrexed disodium and cisplatin may kill more tumor cells
Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival of patients with malignant pleural mesothelioma (MPM) treated with anti-HGF monoclonal antibody AMG 102 in combination with pemetrexed disodium and cisplatin.

SECONDARY OBJECTIVES:

I. To assess the toxicity associated with this regimen in these patients. II. To determine the response rate of patients treated with this regimen. III. To determine the overall survival of patients treated with this regimen. IV. To evaluate multiple potential correlative biomarkers in MPM that are relevant to this combined regimen, including serum HGF and mesothelin levels, c-met expression by IHC in tumor specimens, presence of c-met mutations in tumor, and the presence of thymidylate synthetase (TS) and excision repair cross complementing protein-1 (ERCC1) polymorphisms.

OUTLINE: This is a multicenter study.

Patients receive anti-HGF monoclonal antibody AMG 102 (AMG 102) IV over 1 hour, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients without disease progression may continue AMG 102 IV over 1 hour on day 1, every 3 weeks, as maintenance therapy in the absence of disease progression. Some patients undergo blood sample collection at baseline and periodically during study for correlative biomarker studies. Tumor samples from diagnostic tissue may also be analyzed.

After completion of study therapy, patients are followed up periodically every 3 months for 2 years and then every 6 months for 1 year.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignant Mesothelioma
  • Epithelial Mesothelioma
  • Recurrent Malignant Mesothelioma
  • Sarcomatous Mesothelioma
Intervention  ICMJE
  • Biological: rilotumumab
    Given IV
    Other Names:
    • AMG 102
    • anti-HGF monoclonal antibody AMG 102
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
  • Drug: pemetrexed disodium
    Given IV
    Other Names:
    • ALIMTA
    • LY231514
    • MTA
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (rilotumumab, cisplatin, pemetrexed disodium)
Patients receive anti-HGF monoclonal antibody AMG 102 (AMG 102) IV over 1 hour, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients without disease progression may continue AMG 102 IV over 1 hour on day 1, every 3 weeks, as maintenance therapy in the absence of disease progression.
Interventions:
  • Biological: rilotumumab
  • Drug: cisplatin
  • Drug: pemetrexed disodium
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 23, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2010)
55
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically and cytologically confirmed malignant mesothelioma of the pleura

    • All subtypes allowed
    • Disease not amenable to curative surgery
  • Measurable disease

    • Patients with disease not measurable by standard RECIST criteria (i.e., pleural rinds/thickening only) allowed
    • Pleural effusions or positive bone scans are not considered measurable
  • No prior radiotherapy to the target lesion or measurable lesion unless the site has subsequent evidence of progression
  • Patients who have undergone pleurodesis allowed

    • Post-pleurodesis CT scan required
  • No known or suspected brain metastases
  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 1.5 times ULN
  • ALT and AST ≤ 1.5 times ULN
  • Albumin ≥ 2.5 g/dL
  • Creatinine clearance ≥ 45 mL/min OR serum creatinine ≤ 1.5 times ULN
  • Able to take folic acid and vitamin B12
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must agree to use effective contraception
  • No active infection or serious concomitant systemic disorder in compatible with the study
  • No thrombosis or vascular ischemic events within the last 12 months, including any of the following:

    • Deep venous thrombosis
    • Pulmonary embolism
    • Transient ischemic attack
    • Cerebral infarction
    • Myocardial infarction
  • No peripheral edema ≥ grade 3
  • No serious or non-healing wounds
  • No second primary malignancy except in situ carcinoma of the cervix or breast, other in situ malignancies, adequately treated basal cell carcinoma of the skin, or other malignancy within the past 3 years with no evidence of recurrence
  • No concurrent antiretroviral therapy for HIV-positive patients
  • At least 4 weeks since prior radiotherapy
  • More than 30 days since major surgery procedures or > 14 days since any minor surgical procedure and recovered

    • Central venous catheter placement, fine-needle aspiration, thoracentesis, or paracentesis are not considered major or minor surgical procedures
  • No prior systemic chemotherapy for mesothelioma
  • No prior intracavity cytotoxic drugs or immunomodulators (unless for the purpose of pleurodesis)
  • No prior anti-HGF monoclonal antibody AMG 102, other c-MET, or HGF inhibitors
  • No prior or concurrent anticoagulation therapy within the past 7 days

    • Low-dose Coumadin-type anticoagulants or low-molecular weight heparin for prophylaxis against central venous catheter thrombosis allowed
  • No investigational agents within the past 4 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01105390
Other Study ID Numbers  ICMJE E1B09
NCI-2011-02068 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
U10CA021115 ( U.S. NIH Grant/Contract )
CDR0000670445 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Stevenson Eastern Cooperative Oncology Group
PRS Account National Cancer Institute (NCI)
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP