S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
This study has been terminated.
(Closed due to poor accrual)
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00265785
First received: December 14, 2005
Last updated: October 3, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: July 12, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Lung Cancer |
| Intervention: |
Drug: pemetrexed |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Pemetrexed | Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion. |
Participant Flow: Overall Study
| Pemetrexed | |
|---|---|
| STARTED | 27 |
| Eligible | 26 |
| Eligible and Began Protocol Treatment | 24 |
| COMPLETED | 0 |
| NOT COMPLETED | 27 |
| Adverse Event | 4 |
| Withdrawal by Subject | 3 |
| Progression/Relapse | 15 |
| Not protocol specified | 2 |
| Ineligible | 1 |
| Did not receive protocol treatment | 2 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Pemetrexed | Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion. |
Baseline Measures
| Pemetrexed | |
|---|---|
|
Number of Participants
[units: participants] |
24 |
|
Age
[units: years] Median ( Full Range ) |
68.2
( 49.6 to 82.9 ) |
|
Gender
[units: participants] |
|
| Female | 12 |
| Male | 12 |
|
Ethnicity (NIH/OMB)
[units: participants] |
|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 22 |
| Unknown or Not Reported | 1 |
|
Race (NIH/OMB)
[units: participants] |
|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 17 |
| More than one race | 1 |
| Unknown or Not Reported | 1 |
|
Histology
[units: participants] |
|
| Adenocarcinoma w/BAC features | 18 |
| Bronchioloalveolar | 6 |
|
Number of Metastatic Sites
[units: participants] |
|
| Single | 12 |
| Multiple | 7 |
| None | 5 |
|
Stage
[units: participants] |
|
| IIIB | 0 |
| IV | 24 |
|
Prior EGFR-TKI Therapy
[units: participants] |
|
| No | 19 |
| Yes | 5 |
|
Prior Radiation Therapy
[units: participants] |
|
| Yes | 3 |
| No | 21 |
|
Prior Systemic Treatment
[units: participants] |
|
| Yes | 10 |
| No | 14 |
|
Prior Surgery
[units: participants] |
|
| Yes | 11 |
| No | 13 |
|
Zubbrod Performance Status
[1] [units: participants] |
|
| 0 | 12 |
| 1 | 12 |
|
Smoking Status
[units: participants] |
|
| Current | 5 |
| Former | 16 |
| Never | 3 |
|
Weight Loss Last 6 months
[units: participants] |
|
| < 5% | 20 |
| 5% to < 10% | 3 |
| 10% to 20% | 1 |
| > 20% | 0 |
| [1] | Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. |
|---|
Outcome Measures
| 1. Primary: | Overall Survival [ Time Frame: 0 - 3 years ] |
| 2. Secondary: | Progression-free Survival [ Time Frame: 0 - 3 years ] |
| 3. Secondary: | Response (Confirmed and Unconfirmed, Complete and Partial) [ Time Frame: 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. ] |
| 4. Secondary: | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [ Time Frame: 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. ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623
Organization: SWOG Statistical Center
phone: 206-667-4623
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00265785 History of Changes |
| Other Study ID Numbers: | CDR0000456424, U10CA032102, S0526 |
| Study First Received: | December 14, 2005 |
| Results First Received: | July 12, 2012 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Federal Government |