Lung Neoplasms Clinical Trial
Official title:
Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy
| Verified date | August 2010 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to help answer:
- Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s)
disappear in patients with relapsed lung cancer (lung cancer that has come back after
surgical removal and chemotherapy), and to determine how long this will last
- Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung
cancer live longer
| Status | Terminated |
| Enrollment | 41 |
| Est. completion date | April 2009 |
| Est. primary completion date | June 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy. - You have good kidney, liver, and bone marrow organ function. - You are fully active or able to carry out light work such as housework or office work. Exclusion Criteria: - You have received pemetrexed or gemcitabine in the past for lung cancer - You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past - You are unable to take corticosteroid drugs like dexamethasone - You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study - You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study - You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Caxias Do Sul | |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Porto Alegre | |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santo Andre | |
| India | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bangalore | |
| India | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mumbai | |
| India | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Trivandrum | |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chapel Hill | North Carolina |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chattanooga | Tennessee |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Evanston | Illinois |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Memphis | Tennessee |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miami | Florida |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Minneapolis | Minnesota |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nashville | Tennessee |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Omaha | Nebraska |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saint Louis | Missouri |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Brazil, India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to time of response (up to 17.5 months) | No |
| Secondary | Overall Survival | Overall survival is the number of participants who were alive when the trial was terminated. | baseline to trial termination (17.5 months) | No |
| Secondary | Time to Progressive Disease | baseline to measured progressive disease (up to 17.5 months) | No | |
| Secondary | Duration of Response | time of response to progressive disease (up to 17.5 months) | No | |
| Secondary | Time to Treatment Failure | baseline to stopping treatment (up to 17.5 months) | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03357094 -
Pulmonary Ventilation/Perfusion Imaging for the Prediction of Postoperative Residual Pulmonary Function
|
N/A | |
| Recruiting |
NCT05543954 -
68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients
|
Early Phase 1 | |
| Completed |
NCT01114958 -
Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases
|
Phase 1 | |
| Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
| Completed |
NCT02926768 -
Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT02907606 -
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
|
N/A | |
| Active, not recruiting |
NCT02514512 -
Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking
|
N/A | |
| Completed |
NCT02531737 -
Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With Lung Cancer
|
Phase 2 | |
| Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02284633 -
Blood Sample Monitoring of Patients With EGFR Mutated Lung Cancer
|
||
| Completed |
NCT02106143 -
RejuvenAir™ System Lobectomy Safety and Histology Study
|
N/A | |
| Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
| Enrolling by invitation |
NCT01687647 -
Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure
|
Phase 3 | |
| Completed |
NCT00243685 -
Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis
|
Phase 2/Phase 3 | |
| Completed |
NCT00351962 -
Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours
|
N/A | |
| Completed |
NCT00385177 -
Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00129844 -
Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer
|
Phase 2 | |
| Withdrawn |
NCT00090701 -
A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT01789229 -
Establishment of a Tumor Bank for Tissue Samples
|
||
| Completed |
NCT00069160 -
Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer
|
Phase 2 |