Trial · NCT00265785

S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00265785, Phase 2, Terminated, SWOG Cancer Research Network; results first posted 2012-11-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer. Trials, record NCT00265785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00265785

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Trial

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

Title: S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
NCT number: NCT00265785
Status: Terminated
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Lung Cancer
Interventions: pemetrexed
First posted: 2005-12-15
Last updated: 2012-11-01
Results first posted: 2012-11-01

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Overall Survival	0 - 3 years	Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Secondary	Progression-free Survival	0 - 3 years	Progression is defined as any one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as globabl deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Progression-free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Secondary	Response (Confirmed and Unconfirmed, Complete and Partial)	Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years.	Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
Secondary	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment.	Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Progression-free Survival	0 - 3 years	Eligible and analyzable patients were included in this measure.	months	MEDIAN
PRIMARY	Overall Survival	0 - 3 years	Eligible and analyzable patients were included in this measure.	months	MEDIAN
SECONDARY	Response (Confirmed and Unconfirmed, Complete and Partial)	Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years.	Eligible and analyzable patients with measurable disease at baseline are included in this measure.	percentage of participants	NUMBER
SECONDARY	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment.	Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group17

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

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival	Premetrexed		6	95% Confidence Interval 3 to 14	months
Overall Survival	Premetrexed		25	95% Confidence Interval 15 to 36	months
Response (Confirmed and Unconfirmed, Complete and Partial)	Premetrexed		29	95% Confidence Interval 10 to 56	percentage of participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Premetrexed	ALT, SGPT (serum glutamic pyruvic transaminase)	1		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Premetrexed	AST, SGOT	1		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Premetrexed	Diarrhea	1		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Premetrexed	Dyspnea (shortness of breath)	1		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Premetrexed	Fatigue (asthenia, lethargy, malaise)	3		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Premetrexed	Febrile neutropenia	1		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Premetrexed	Glucose, serum-high (hyperglycemia)	3		Participants

1 to 10 of 17Source ClinicalTrials.gov

See all 17 results by group

Participant flow5

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pemetrexed	27
Overall Study	Eligible	Pemetrexed	26
Overall Study	Eligible and Began Protocol Treatment	Pemetrexed	24
Overall Study	COMPLETED	Pemetrexed	0
Overall Study	NOT COMPLETED	Pemetrexed	27

Source ClinicalTrials.gov

Adverse events34

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
other	Hemoglobin	Blood and lymphatic system disorders	Pemetrexed	13	24
other	Constipation	Gastrointestinal disorders	Pemetrexed	11	24
other	Diarrhea	Gastrointestinal disorders	Pemetrexed	7	24
other	Mucositis/stomatitis (clinical exam) - Oral cavity	Gastrointestinal disorders	Pemetrexed	2	24
other	Mucositis/stomatitis (functional/symptomatic) - Oral cavity	Gastrointestinal disorders	Pemetrexed	2	24
other	Nausea	Gastrointestinal disorders	Pemetrexed	11	24
other	Vomiting	Gastrointestinal disorders	Pemetrexed	6	24
other	Edema: limb	General disorders	Pemetrexed	4	24
other	Fatigue (asthenia, lethargy, malaise)	General disorders	Pemetrexed	16	24
other	Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)	General disorders	Pemetrexed	2	24

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pemetrexed
Total, other adverse events	Pemetrexed	22	24
Total, serious adverse events	Pemetrexed	0	24

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

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/NCT00265785

GET https://conductscience.org/api/trials/v1/NCT00265785/events?page=2

API reference For AI assistants