Trial · NCT00087698

Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma

NCT00087698, Phase 2, Completed, Eli Lilly and Company; results first posted 2009-03-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma. Trials, record NCT00087698. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00087698

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
NCT number: NCT00087698
Status: Completed
Phases: Phase 2
Enrollment: 77 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Pleural Neoplasms
Interventions: pemetrexed, cisplatin
First posted: 2004-07-16
Last updated: 2009-05-12
Results first posted: 2009-03-17

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pathological Complete Response	Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)	Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy \[EPP\]). Resected tissue or pleural fluid should be sent for pathological and histological evaluation.
Secondary	The 1 and 2 Year Disease-Free Survival Rate (Percentage)	1 year and 2 years	Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.
Secondary	Overall Tumor Response	baseline to measured progressive disease	The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.
Secondary	Time to Treatment Failure	baseline to stopping treatment	Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.
Secondary	Time to Progressive Disease	baseline to measured progressive disease	Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.
Secondary	Overall Survival Time	baseline to date of death from any cause	Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pathological Complete Response	Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)	All participants who had undergone surgery.	participants	NUMBER
SECONDARY	The 1 and 2 Year Disease-Free Survival Rate (Percentage)	1 year and 2 years	All participants who had undergone surgery.	percentage of participants	MEAN
SECONDARY	Overall Tumor Response	baseline to measured progressive disease	Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug.	participants	NUMBER
SECONDARY	Time to Treatment Failure	baseline to stopping treatment	All participants who had undergone surgery.	months	MEAN
SECONDARY	Time to Progressive Disease	baseline to measured progressive disease	All participants who had undergone surgery.	months	MEAN
SECONDARY	Overall Survival Time	baseline to date of death from any cause	All participants who had undergone surgery.	months	MEAN

Source ClinicalTrials.gov

Results by group11

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Pathological Complete Response	Pemetrexed		3		participants
The 1 and 2 Year Disease-Free Survival Rate (Percentage)	Pemetrexed	1-Year Disease-Free Rate	61.40	95% Confidence Interval 47.53 to 72.63	percentage of participants
The 1 and 2 Year Disease-Free Survival Rate (Percentage)	Pemetrexed	2-Year Disease-Free Rate	33.24	95% Confidence Interval 21.45 to 45.47	percentage of participants
Overall Tumor Response	Pemetrexed	Complete Response	1		participants
Overall Tumor Response	Pemetrexed	Partial Response	24		participants
Overall Tumor Response	Pemetrexed	Stable Disease	36		participants
Overall Tumor Response	Pemetrexed	Progressive Disease	5		participants
Overall Tumor Response	Pemetrexed	Unknown/Unavailable	11		participants
Time to Treatment Failure	Pemetrexed		18.30	Full Range 1.71 to 41.89	months
Time to Progressive Disease	Pemetrexed		14.98	Full Range 2.56 to 46.00	months

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pemetrexed	77
Overall Study	COMPLETED	Pemetrexed	41
Overall Study	NOT COMPLETED	Pemetrexed	36

Source ClinicalTrials.gov

Adverse events75

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Pemetrexed	17	77	22
other	Leukopenia	Blood and lymphatic system disorders	Pemetrexed	5	77	8
other	Neutropenia	Blood and lymphatic system disorders	Pemetrexed	8	77	10
other	Tachycardia	Cardiac disorders	Pemetrexed	7	77	7
other	Tinnitus	Ear and labyrinth disorders	Pemetrexed	12	77	13
other	Lacrimation increased	Eye disorders	Pemetrexed	5	77	5
other	Vision blurred	Eye disorders	Pemetrexed	5	77	6
other	Abdominal distention	Gastrointestinal disorders	Pemetrexed	4	77	6
other	Abdominal pain	Gastrointestinal disorders	Pemetrexed	5	77	6
other	Constipation	Gastrointestinal disorders	Pemetrexed	45	77	62

1 to 10 of 75Source ClinicalTrials.gov

See all 75 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Pemetrexed
Total, other adverse events	Pemetrexed	77
Total, serious adverse events	Pemetrexed	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23324131	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00087698

GET https://conductscience.org/api/trials/v1/NCT00087698/events?page=2

API reference For AI assistants