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

NCT01105390 | Withdrawn Phase 2

• 4 other identifiers: E1B09NCI-2011-02068U10CA021115CDR0000670445
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Advanced Malignant Mesothelioma; Epithelial Mesothelioma; Recurrent Malignant Mesothelioma; Sarcomatous Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

Secondary Outcomes (1)

• Toxicity defined as a grade 4 hemorrhagic event or a grade 5 event

  Up to 30 days after completion of study treatment

Study Arms (1)

Treatment (rilotumumab, cisplatin, pemetrexed disodium)

EXPERIMENTAL

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.

Biological: rilotumumab; Drug: cisplatin; Drug: pemetrexed disodium; Other: laboratory biomarker analysis

Interventions

rilotumumab BIOLOGICAL

Given IV

Also known as: AMG 102, anti-HGF monoclonal antibody AMG 102

Treatment (rilotumumab, cisplatin, pemetrexed disodium)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (rilotumumab, cisplatin, pemetrexed disodium)

pemetrexed disodium DRUG

Given IV

Also known as: ALIMTA, LY231514, MTA

Treatment (rilotumumab, cisplatin, pemetrexed disodium)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (rilotumumab, cisplatin, pemetrexed disodium)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

MeSH Terms

Conditions

Mesothelioma, Malignant; Solitary Fibrous Tumor, Pleural

Interventions

rilotumumab; Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Solitary Fibrous Tumors; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• James Stevenson

  Eastern Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Last Updated: August 2, 2013

Record last verified: 2013-01