| July 12, 2004 |
| May 1, 2009 |
| September 2003 |
| February 2008 (final data collection date for primary outcome measure) |
| Pathological Complete Response [ Time Frame: Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks) ] [ Designated as safety issue: No ] |
| Pathological response in patients treated with preoperative chemotherapy, radiation and subsequent surgery. |
| Complete list of historical versions of study NCT00087698 on ClinicalTrials.gov Archive Site |
- The 1 and 2 Year Disease-Free Survival Rate (Percentage) [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
- Overall Tumor Response [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
- Time to Treatment Failure [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]
- Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
- Overall Survival Time [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
|
- - To determine the 1 and 2 year disease-free survival, and median survival.
- - To determine clinical response rate measured by radiological assessment.
- - To characterize the quantitative and qualitative toxicities of chemotherapy, surgery and radiation in this patient population.
- - To determine the pattern of relapse (local versus metastatic).
- - To measure time-to-event efficacy variables including:
- time to objective tumor response for responding patients; time to treatment failure; time to progressive disease; overall survival
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| |
| Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma |
| A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma |
This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored. |
| |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Pleural Neoplasms |
- Drug: pemetrexed
- Drug: cisplatin
|
| Experimental: chemotherapy, surgery then chest radiation x 54 gray (Gy) |
| |
| |
| Completed |
| 77 |
| February 2008 |
| February 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded if they meet ANY of the following criteria:
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Have previously completed or withdrawn from this study or any other study investigating pemetrexed
- Pregnancy or breast-feeding
- Serious concomitant systemic disorders (i.e. active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
- Second active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin, low grade (Gleason score less than or equal to 6), localized adenocarcinoma of the prostate or other malignancy treated at least 2 years previously with no evidence of recurrence
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00087698 |
| Chief Medical Officer, Eli Lilly |
| 7216, H3E-US-JMGA |
| Eli Lilly and Company |
|
| Study Director: |
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 |
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|
| Eli Lilly and Company |
| May 2009 |