A Comparison of Two Doses of Pemetrexed in Patients Who H... | NCT00078260

Studies
A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung Cancer

NCT00078260

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Sep 12, 2019Actual

Enrollment

589Actual

Phase

Phase 3

Conditions

Non-Small Cell Lung Cancer

Interventions

pemetrexed

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H3E-MC-JMGX	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Oct 2006Actual

Completion Date

Apr 2008Actual

First Submitted Date

Feb 20, 2004

First Submission Date that Met QC Criteria

Feb 23, 2004

First Posted Date

Feb 24, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2019

Last Update Posted Date

Sep 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purposes of this study are to determine:

the safety of pemetrexed and any side effects that might be associated with it
how much pemetrexed should be given to patients.

It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed.

Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

589Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: pemetrexed
B	Experimental		Drug: pemetrexed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pemetrexed	Drug	A: 500 mg/m2, IV, q 21 days until disease progression B: 900 mg/m2, IV, q 21 days until disease progression	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		baseline to date of death from any cause

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival		baseline to measured progressive disease
Tumor response rate		baseline to measured progressive disease
Adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy.
Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
No more than two prior systemic anti-cancer therapies will be allowed.
Prior radiation therapy is allowed to less than 25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.

Exclusion Criteria:

Pregnancy.
Breast-feeding.
Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
Inability or unwillingness to take folic acid or vitamin B12 supplementation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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.		Ankara			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18283036	Result	Cullen MH, Zatloukal P, Sorenson S, Novello S, Fischer JR, Joy AA, Zereu M, Peterson P, Visseren-Grul CM, Iscoe N. A randomized phase III trial comparing standard and high-dose pemetrexed as second-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2008 May;19(5):939-45. doi: 10.1093/annonc/mdm592. Epub 2008 Feb 17.

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574