NCT00191308

Brief Summary

The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2005

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

3 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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 20, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 21, 2011

Status Verified

October 1, 2011

Enrollment Period

3.2 years

First QC Date

September 12, 2005

Results QC Date

March 16, 2010

Last Update Submit

October 13, 2011

Conditions

Non-Small Cell Lung CancerCarcinoma

Outcome Measures

Primary Outcomes (1)

  • High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood

    Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.

    Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)

Secondary Outcomes (4)

  • Percentage of Participants With Objective Tumor Response (Response Rate)

    Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)

  • Duration of Response

    Time of response to disease progression (up to 44.4 months)

  • Disease Free Survival (DFS)

    Treatment start to disease progression or death from any cause (up to 45.5 months)

  • Overall Survival (OS)

    Treatment start to death from any cause (up to 47.6 months)

Study Arms (1)

Pemetrexed + Cisplatin

EXPERIMENTAL

Pemetrexed: 500 milligrams per square meter (mg/m\^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs

Drug: pemetrexedDrug: cisplatinProcedure: Radical Non-Small Cell Lung Cancer (NSCLC) surgery

Interventions

pemetrexedDRUG

500 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs

Also known as: LY231514, Alimta
Pemetrexed + Cisplatin
cisplatinDRUG

75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs

Pemetrexed + Cisplatin
Radical Non-Small Cell Lung Cancer (NSCLC) surgeryPROCEDURE

All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.

Pemetrexed + Cisplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pathologic documentation of non-small cell lung cancer (NSCLC)
  • tumor must be accessible by bronchoscopy for tumor tissue sample collection
  • patients must have lung cancer with clinical stage IB, II, IIIA
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • patients must not have received prior systemic chemotherapy or radiation therapy for NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment)

You may not qualify if:

  • bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast tumors)
  • pregnant or breast feeding patients
  • patients who 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
  • patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
  • unwillingness to take folic acid or vitamin B12 supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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.

Bystra, 43-360, Poland

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.

Poznan, 60-569, Poland

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.

Warsaw, 02-781, Poland

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma

Interventions

PemetrexedCisplatinSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Limitations and Caveats

Trial enrollment was terminated early due to lack of eligible participants.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

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

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

May 1, 2005

Primary Completion

July 1, 2008

Study Completion

December 1, 2010

Last Updated

October 21, 2011

Results First Posted

April 20, 2010

Record last verified: 2011-10

Locations

PL(3)