NCT00350792

Brief Summary

A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2006

Typical duration 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

First Submitted

Initial submission to the registry

July 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1 month until next milestone

Results Posted

Study results publicly available

December 9, 2009

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

2.3 years

First QC Date

July 10, 2006

Results QC Date

November 5, 2009

Last Update Submit

October 11, 2010

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)

    Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.

    baseline to measured objective tumor response (up to six 21-day cycles)

Secondary Outcomes (3)

  • Time to Treatment Failure

    baseline to stopping treatment (up to six 21-day cycles)

  • Overall Survival

    baseline to date of death from any cause (up to 14.5 months)

  • Estimated Probability of One Year Progression-free Survival

    baseline to measured progressive disease or death, 1 year

Other Outcomes (1)

  • Time to Treatment Failure

    baseline to stopping treatment (up to six 21-day cycles)

Study Arms (1)

Pemetrexed + Carboplatin

EXPERIMENTAL

Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.

Drug: pemetrexedDrug: carboplatin

Interventions

pemetrexedDRUG

500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles

Also known as: LY231514, Alimta
Pemetrexed + Carboplatin
carboplatinDRUG

Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Pemetrexed + Carboplatin

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV
  • No previous chemotherapy for lung cancer
  • Men and women \> or = 70 years
  • At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors \[RECIST\]criteria)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1

You may not qualify if:

  • Treatment within the last 30 days with a drug that has not received regulatory approval
  • Serious systemic disorders
  • Inability to discontinue administration of aspirin or anti-inflammatory non steroid
  • Concurrent administration of any other antitumor therapy
  • Brain metastasis

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.

Bobigny, 93009, France

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.

Brest, 29609, France

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.

Caen, 14076, France

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.

Le Mans, 72000, France

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.

Lille, 59000, France

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.

Nantes, 44202, France

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.

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PemetrexedCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicCoordination ComplexesOrganic Chemicals

Results Point of Contact

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

Study Officials

  • 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

Study Record Dates

First Submitted

July 10, 2006

First Posted

July 11, 2006

Study Start

August 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2009

Last Updated

October 13, 2010

Results First Posted

December 9, 2009

Record last verified: 2010-10

Locations

FR(7)