Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non Small Cell Lung Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 21, 2005

Last Updated Date

December 21, 2007

Start Date ^†

December 2005

Current Primary Outcome Measures ^†

To assess the feasibility of post surgery chemotherapy [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00269152 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: baseline to date of death from any cause, assessed at 3 years ] [ Designated as safety issue: Yes ]
Disease free survival [ Time Frame: length of time disease free, assessed at 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

To characterize the quantitative and qualitative potential toxicities and the necessity of dose reductions and cycle delays due to toxicities of either treatment arm.
To assess time to event efficacy parameters in both treatment arms including
Overall survival (assessed after 3 years).
3 year disease free survival.
To assess biomarkers relevant to pemetrexed and disease state and their correlation to clinical outcome (including overall survival, 3 year disease free survival and toxicity).

Descriptive Information

Brief Title ^†

Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non Small Cell Lung Cancer

Official Title ^†

A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer

Brief Summary

This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in patients with completely resected, stage Ib or IIa/IIb NSCLC.

A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^†

Non-Small Cell Lung Cancer

Intervention ^†

Drug: pemetrexed
Drug: cisplatin
Drug: carboplatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

123

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Histologically proven non-small cell lung cancer stage Ib, IIa or IIb
Must have complete tumor resection by pneumonectomy or lobectomy
Must have been surgically proven to be N2 negative

Exclusion Criteria:

Serious concomitant systemic disorder
Post-operative complications or other surgery related conditions
A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at leat 5 years ago.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France, Germany, Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00269152

Responsible Party

Chief Medical Officer, Eli Lilly

Secondary IDs ^††

H3E-SB-S089

Study Sponsor ^†

Eli Lilly and Company

Collaborators ^††

Investigators ^†

Study Chair:

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

Information Provided By

Eli Lilly and Company

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.