Brief Title
Safety Confirmation Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
Official Title
Safety Confirmation Study of LY231514 Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
Brief Summary
To investigate safety of pemetrexed combined with cisplatin for chemo therapy-naive patients
with malignant pleural mesothelioma
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
To investigate safety profile when administered pemetrexed combined with cisplatin in malignant pleural mesothelioma patients
Secondary Outcome
To investigate efficacy when administered pemetrexed combined with cisplatin in malignant pleural mesothelioma patients
Condition
Malignant Pleural Mesothelioma
Intervention
pemetrexed
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
October 2006
Completion Date
February 2007
Eligibility Criteria
Inclusion Criteria:
- Histologic diagnosis of malignant pleural mesothelioma
- Not candidates for curative surgery. Patients will be clinically staged using the IMIG
TNM staging criteria
- Not receive prior systemic chemotherapy
- Patients must have measurable lesions, which are diagnosed by CT, or MRI scan within
28 days before administration
- More than 20 years and less than 75 years of age
- ECOG Performance status score: 0 - 1
- Prior radiation therapy is allowed to < 25% of the bone marrow. Prior radiotherapy
must be completed at least 21 days before study enrollment, and the patients must have
recovered from the toxic effects of the treatment prior to study enrollment.
- Prior surgeries must be completed at least 21 days before study enrollment, and the
patients must have recovered from the effects of the operation.However, regarding
examination of thoracotomy or celiotomy, etc. if the investigator or sub-investigator
judges that there are no influences of surgery and no problems for participation of
patients in this study, e.g. safety security, there should be at least 14 days from
the surgery day to patient registration date
- Patients who have adequate organ function Hemoglobin: no less than 9g/dl, Absolute
neutrophil count: no less than 2,000/mm3, Platelet count: no less than
100,000/mm3,Serum albumin: no less than 2.5g/dL,AST (GOT) and ALT (GPT): no more than
2.5 x the upper limit of reference values at each site (no more than 5 x the upper
limit of reference values at each site is acceptable if liver has tumor involvement),
Total bilirubin: no more than 1.5 x the upper limit of reference values at each
site,Serum creatinine: no more than the upper limit of reference values at each site,
SpO2: no less than 92%, ECG: normal (In the case of the ECG was marked abnormal
waveshape, when the investigator or sub-investigator judges that there is no safety
issue for the patient, administration can be done), 24hr-creatinine clearance or
calculated creatinine clearance: no less than 45mL/min
- Estimated life expectancy of at least 90 days from the registration date
- Patients must be hospitalized from the start of the first cycle until the start of the
second cycle of the combination therapy, in principle (Only in case investigator or
sub-investigator judges that there are no safety issues, patients can receive the
therapy as outpatients from the middle of Cycle 1)
- Male and female patients with reproductive potential must use an approved
contraceptive method if appropriate (eg, intrauterine device [IUD], birth control
pills, or barrier device) during and for 90 days after study therapy. Females with
childbearing potential must have a negative serum or urine pregnancy test within 7
days prior to study enrollment.
- Signed informed consent from patient
Exclusion Criteria:
- Serious or uncontrolled concomitant systemic disorders
- Active systemic infection
- Active, double cancer (patients with synchronous double cancers or asynchronous double
cancers with non-disease period of no more than 5 years)(except in situ carcinoma of
the cervix or adequately treated basal cell carcinoma of the skin)
- Patients who have symptomatic brain metastases or those who have brain metastases
which require treatment
- Presence of clinically detectable third-space fluid collections, for example, ascites
or pleural effusions that cannot be controlled by drainage.
- 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.
- Having a history of sensitivity to platinum agent, folic acid or vitamin B12
- Women who are pregnant, breast-feeding or could be pregnant or women who hope to get
pregnant during or within 90 days after the study.
- Man who hopes their partner will become pregnant during or within 90 days after the
study.
- Patients who have neurotoxicity which is no less than CTC grade 2 at study entry.
- Inability to interrupt salicylates of other nonsteroidal anti-inflammatory agents for
a 5-day period(8-day period for long-acting agents such as piroxicam).
- Inability and unwillingness to take folic acid or vitamin B12 supplementation.
- Plane chest X-rays show widely diffuse images that have been caused by interstitial
pneumonia.
- Patients who have been judged inadequate for the study by the investigator or
sub-investigator
Gender
All
Ages
20 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
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), ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT00386815
Organization ID
10512
Secondary IDs
H3E-JE-ME02
Study Sponsor
Eli Lilly and Company
Study Sponsor
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
Verification Date
April 2007