Pleural NeoplasmsPhase 2NCT00087698
Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
A Phase 2 study testing pemetrexed and cisplatin in people with Pleural Neoplasms, run by Eli Lilly and Company at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Neoplasms
- What is being tested?
- pemetrexed and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2003to Feb 2008
- Phase
- Phase 2
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
- 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
Who cannot join
- 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- Have previously completed or withdrawn from this study or any other study investigating pemetrexed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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
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.
Baltimore, Maryland
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.
Boston, Massachusetts
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.
Chicago, Illinois
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.
Detroit, Michigan
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.
Houston, Texas
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.
New York, New York
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
About this study
Official title: A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
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.
- Conditions
- Pleural Neoplasms
- Being tested
- pemetrexed, cisplatin
- Medical subject headings
- Pleural Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Also called LY231514, Alimta
500 mg/m2, intravenous (IV), every 21 days x 4 cycles
cisplatinDrug
75 mg/m2, intravenous (IV), every 21 days x 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | chemotherapy, surgery then chest radiation x 54 gray (Gy) Receives: Drug: pemetrexed; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.
Measured: 1 year and 2 years
Overall Tumor Response
The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.
Measured: baseline to measured progressive disease
Time to Treatment Failure
Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.
Measured: baseline to stopping treatment
Time to Progressive Disease
Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.
Measured: baseline to measured progressive disease
Overall Survival Time
Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).
Measured: baseline to date of death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2004 (estimated)
- Study startSep 2003
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087698
- Sponsor's protocol ID
- 7216
- Other IDs
- H3E-US-JMGA
- Status last verified
- May 2009
- First submitted
- 12 Jul 2004
- Last updated
- 12 May 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23324131