Carcinoma, Non-Small-Cell-Lung Cancer Clinical Trial
Official title:
Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer
| Verified date | November 2007 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Turkey: Ministry of Health |
| Study type | Interventional |
Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | December 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - define histologic or cytologic diagnosis of non small cell lung cancer. - determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer. - define performance status of 0-1 on ECOG scale - do not have any prior tumor therapy - to be suitable for curative resection Exclusion Criteria: - to have any treatment within the last 30 days with any investigational drug. - to get concurrent administration of any other tumor therapy - to be pregnant - to have poorly controlled diabetes mellitus - to have serious concomitant disorders. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Turkey | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer | |||
| Secondary | To evaluate the safety of neo-adjuvant chemotherapy with gemcitabine / cisplatin | |||
| Secondary | To determine the complete tumor resection rate | |||
| Secondary | To evaluate overall survival and time to documented disease progression |