NCT00386815

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 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

Study Start

First participant enrolled

October 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 11, 2007

Status Verified

April 1, 2007

First QC Date

October 10, 2006

Last Update Submit

April 10, 2007

Conditions

Malignant Pleural Mesothelioma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • To investigate efficacy when administered pemetrexed combined with cisplatin in malignant pleural mesothelioma patients

Interventions

pemetrexedDRUG
cisplatinDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

Aichi, 464-8681, Japan

Location

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, 811-1395, Japan

Location

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, 060-8648, Japan

Location

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.

Hyōgo, 663-8501, Japan

Location

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, 702-8055, Japan

Location

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, 589-8511, Japan

Location

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, 104-0045, Japan

Location

Related Links

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

PemetrexedCisplatin

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung 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

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

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

October 10, 2006

First Posted

October 12, 2006

Study Start

October 1, 2006

Study Completion

February 1, 2007

Last Updated

April 11, 2007

Record last verified: 2007-04

Locations

JP(7)