Safety Confirmation Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00386815
First received: October 10, 2006
Last updated: April 10, 2007
Last verified: April 2007
  Purpose

To investigate safety of pemetrexed combined with cisplatin for chemo therapy-naive patients with malignant pleural mesothelioma


Condition Intervention Phase
Malignant Pleural Mesothelioma
Drug: pemetrexed
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Confirmation Study of LY231514 Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To investigate safety profile when administered pemetrexed combined with cisplatin in malignant pleural mesothelioma patients

Secondary Outcome Measures:
  • To investigate efficacy when administered pemetrexed combined with cisplatin in malignant pleural mesothelioma patients

Estimated Enrollment: 20
Study Start Date: October 2006
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386815

Locations
Japan
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.
Aichi, Japan, 464-8681
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.
Fukuoka, Japan, 811-1395
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.
Hokkaido, Japan, 060-8648
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.
Hyogo, Japan, 663-8501
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.
Okayama, Japan, 702-8055
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.
Osaka, Japan, 589-8511
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.
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00386815     History of Changes
Other Study ID Numbers: 10512, H3E-JE-ME02
Study First Received: October 10, 2006
Last Updated: April 10, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Cisplatin
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014