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Advanced Malignant MesotheliomaPhase 2NCT01105390

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

A Phase 2 study testing rilotumumab, cisplatin and pemetrexed disodium in people with Advanced Malignant Mesothelioma and Epithelial Mesothelioma, run by National Cancer Institute (NCI).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
rilotumumab, cisplatin and pemetrexed disodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2010to May 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 42Show fewer
  • 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

Who cannot join

None listed.

About this study

Official title: A Phase II Trial of AMG 102 in Combination With Pemetrexed and Cisplatin in Patients With Malignant Pleural Mesothelioma

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
rilotumumab, cisplatin, pemetrexed disodium, laboratory biomarker analysis
Medical subject headings
Mesothelioma, Malignant, Solitary Fibrous Tumor, Pleural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rilotumumabBiological

    Also called AMG 102, anti-HGF monoclonal antibody AMG 102

    Given IV

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • pemetrexed disodiumDrug

    Also called ALIMTA, LY231514, MTA

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01105390
Study groupRoleWhat they receive
Treatment (rilotumumab, cisplatin, pemetrexed disodium)ExperimentalPatients 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.
Receives: Biological: rilotumumab; Drug: cisplatin; Drug: pemetrexed disodium; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: From registration to clinical evidence of disease progression or death without progression, assessed up to 3 years

Secondary outcomes (1)

  1. Toxicity defined as a grade 4 hemorrhagic event or a grade 5 event

    Graded using the NCI CTCAE.

    Measured: Up to 30 days after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionMay 2011

Why it stopped: withdrawn

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01105390
Sponsor's protocol ID
E1B09
Other IDs
NCI-2011-02068, U10CA021115, CDR0000670445
Status last verified
Jan 2013
First submitted
15 Apr 2010
Last updated
2 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rilotumumab, cisplatin and pemetrexed disodium in people with Advanced Malignant Mesothelioma and Epithelial Mesothelioma, run by National Cancer Institute (NCI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From registration to clinical evidence of disease progression or death without progression, assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01105390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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