Brief Summary

This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Sep 2003

Typical duration for phase_2

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

Study Start

First participant enrolled

September 1, 2003

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2004

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2004

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

March 17, 2009

Completed

Last Updated

May 12, 2009

Status Verified

May 1, 2009

Enrollment Period

4.4 years

First QC Date

July 12, 2004

Results QC Date

February 16, 2009

Last Update Submit

May 1, 2009

Conditions

Pleural Neoplasms

Outcome Measures

Primary Outcomes (1)

Pathological Complete Response
Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy \[EPP\]). Resected tissue or pleural fluid should be sent for pathological and histological evaluation.
Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)

Secondary Outcomes (5)

The 1 and 2 Year Disease-Free Survival Rate (Percentage)
1 year and 2 years
Overall Tumor Response
baseline to measured progressive disease
Time to Treatment Failure
baseline to stopping treatment
Time to Progressive Disease
baseline to measured progressive disease
Overall Survival Time
baseline to date of death from any cause

Study Arms (1)

A

EXPERIMENTAL

chemotherapy, surgery then chest radiation x 54 gray (Gy)

Drug: pemetrexedDrug: cisplatin

Interventions

pemetrexedDRUG

500 mg/m2, intravenous (IV), every 21 days x 4 cycles

Also known as: LY231514, Alimta

cisplatinDRUG

75 mg/m2, intravenous (IV), every 21 days x 4 cycles

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients will be clinically staged using AJCC/UICC TNM staging criteria. Eligible stages:
Patients must be M0
Patients with T1, T2, and T3 disease (without cardiac involvement) are eligible (T status can be established clinically and radiologically or at exploratory thoracotomy without surgical resection
Patients with N0, N1,or N2 disease are eligible
Performance status of 0 to 1 on the ECOG performance status schedule.
No prior systemic chemotherapy and no prior intracavitary cytotoxic drugs or immunomodulators, unless given for the purpose of chemical pleurodesis
No previous radiation therapy
Estimated life expectancy of at least 12 weeks

You may not qualify if:

Patients will be excluded if they meet ANY of the following criteria:
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Have previously completed or withdrawn from this study or any other study investigating pemetrexed
Pregnancy or breast-feeding
Serious concomitant systemic disorders (i.e. active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
Second active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin, low grade (Gleason score less than or equal to 6), localized adenocarcinoma of the prostate or other malignancy treated at least 2 years previously with no evidence of recurrence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (7)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Francisco, California, United States

Location

Chicago, Illinois, United States

Location

Baltimore, Maryland, United States

Location

Boston, Massachusetts, United States

Location

Detroit, Michigan, United States

Location

New York, New York, United States

Location

Houston, Texas, United States

Location

Related Publications (1)

Federico R, Adolfo F, Giuseppe M, Lorenzo S, Martino DT, Anna C, Adriano P, Gino C, Francesca R, Matteo C, Gbenga K, Paolo M, Francesco F. Phase II trial of neoadjuvant pemetrexed plus cisplatin followed by surgery and radiation in the treatment of pleural mesothelioma. BMC Cancer. 2013 Jan 16;13:22. doi: 10.1186/1471-2407-13-22.
PMID: 23324131DERIVED

MeSH Terms

Conditions

Pleural Neoplasms

Interventions

PemetrexedCisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 12, 2004

First Posted

July 16, 2004

Study Start

September 1, 2003

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

May 12, 2009

Results First Posted

March 17, 2009

Record last verified: 2009-05

Locations

US(7)

Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations