Brief Summary

This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin for patients with unresectable, advanced gastric cancer who had no prior palliative chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase 2, which has been completed and now a total of 60 qualified patients will be enrolled in the phase 2 of this study. The treating physician will determined the maximum number of cycles of pemetrexed plus cisplatin that a patient may receive in this study.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Mar 2004

Longer than P75 for phase_1

Geographic Reach

4 countries

8 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

4.3 years study duration

Study Start

First participant enrolled

March 1, 2004

Completed

2.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

September 28, 2009

Completed

Last Updated

September 28, 2009

Status Verified

August 1, 2009

Enrollment Period

4.3 years

First QC Date

April 28, 2006

Results QC Date

July 9, 2009

Last Update Submit

August 19, 2009

Conditions

Neoplasm, Gastric

Outcome Measures

Primary Outcomes (1)

Objective Best Tumor Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)

Secondary Outcomes (3)

Duration of Response
time of response to progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)
Progression Free Survival
baseline to measured progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)
Overall Survival
baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment)

Study Arms (1)

A

EXPERIMENTAL

Drug: pemetrexedDrug: cisplatin

Interventions

pemetrexedDRUG

Phase 1 - dose escalating: 600 mg/m2 level 1, 700 mg/m2 level 2, 800 mg/m2 level 3, 900 mg/m2 level 4, intravenous (IV), every 21 days, until disease progression Phase 2 - 700 mg/m2, intravenous (IV), every 21 days, until disease progression

Also known as: LY231514, Alimta

cisplatinDRUG

75 mg/m2, intravenous (IV), every 21 days, until disease progression

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histological proven diagnosis of adenocarcinoma of the stomach
Stage IV disease not amenable to curative surgery.
Disease status must be that of measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale.
Adequate organ functions

You may not qualify if:

Prior palliative chemotherapy for advanced gastric cancer.
Pregnancy and breast feeding.
Known or suspected brain metastasis and secondary primary malignancy
Inability to interrupt aspirin, or other non-steroidal anti-inflammatory agents for a 5-day period.
Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Concurrent administration of any other tumor therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (8)

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.

Buenos Aires, 1264, Argentina

Location

Tucumain, 4000, Argentina

Location

Ciudad Obregón, 85100, Mexico

Location

Guadalajara, 44280, Mexico

Location

Seoul, 136-705, South Korea

Location

Tainan, 704, Taiwan

Location

Taipei, 112, Taiwan

Location

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

PemetrexedCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach 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

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559, Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

April 28, 2006

First Posted

May 3, 2006

Study Start

March 1, 2004

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 28, 2009

Results First Posted

September 28, 2009

Record last verified: 2009-08

Locations

TW(3)ME(2)KR(1)AR(2)

Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations