NCT00087698 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2009-05-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Pathological Complete Response

→

outcome · POSTED

The 1 and 2 Year Disease-Free Survival Rate (Percentage)

→

outcome · POSTED

Overall Tumor Response

→

outcome · POSTED

Time to Treatment Failure

→

outcome · POSTED

Time to Progressive Disease

→

outcome · POSTED

Overall Survival Time

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Patients will be clinically staged using AJCC/UICC TNM staging criteria. Eligible stages: 1. Patients must be M0 2. 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 3. 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 Exclusion Criteria: 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that has not received regulatory approval for any indication at the time of study entry * Have previously completed or withdrawn from this study or any other study investigating pemetrexed * Pregnancy or breast-feeding * Serious concomitant systemic disorders (i.e. active infection)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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
chemotherapy, surgery then chest radiation x 54 gray (Gy)
intervention Names
Drug: pemetrexed
Drug: cisplatin
label
A
type
EXPERIMENTAL

interventions

arm Group Labels
A
description
500 mg/m2, intravenous (IV), every 21 days x 4 cycles
name
pemetrexed
other Names
LY231514
Alimta
type
DRUG
arm Group Labels
A
description
75 mg/m2, intravenous (IV), every 21 days x 4 cycles
name
cisplatin
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 77
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Pathological Complete Response
time Frame
Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)

secondary Outcomes

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

Full study description

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.

Source references

references

citation
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
23324131
type
DERIVED