First Line Chemotherapy Treatment of Advanced NSCLC
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00308750 |
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Recruitment Status :
Completed
First Posted : March 30, 2006
Last Update Posted : June 2, 2010
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The purposes of this study are to determine:
The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or docetaxel with carboplatin and any side effects that might be associated with the combination of these drugs.
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can help patients with non-small cell lung cancer live longer, compared with the combination of docetaxel and carboplatin.
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can make your tumor smaller or disappear, and for how long, compared with the combination of docetaxel and carboplatin.
The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or docetaxel with carboplatin have on your disease related symptoms.
The relation of smoking history and hormone replacement therapy (for women only) may have to your lung cancer treatment results.
The effects of certain genes and proteins in samples of your blood and tumor tissue in order to learn more about non-small cell lung cancer and how enzastaurin works in the body.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-small Cell Lung Cancer | Drug: enzastaurin Drug: pemetrexed Drug: docetaxel Drug: carboplatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 217 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open-label Phase II Study of Pemetrexed (Alimta) Plus Carboplatin With or Without Enzastaurin Hydrochloride, or Docetaxel Plus Carboplatin as First Line Treatment in Patients With Advanced Stage Non-small Cell Lung Cancer (NSCLC) |
| Study Start Date : | March 2006 |
| Actual Primary Completion Date : | July 2009 |
| Actual Study Completion Date : | July 2009 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: A |
Drug: enzastaurin
1125-1200 mg loading dose then 500 mg, oral, daily, until disease progression
Other Name: LY317615 Drug: pemetrexed 500 mg/m2, IV, q 21 days, six 21 day cycles or progressive disease
Other Names:
Drug: carboplatin AUC 6, IV, q 21 days, six 21 day cycles or progressive disease |
| Experimental: B |
Drug: pemetrexed
500 mg/m2, IV, q 21 days, six 21 day cycles or progressive disease
Other Names:
Drug: carboplatin AUC 6, IV, q 21 days, six 21 day cycles or progressive disease |
| Active Comparator: C |
Drug: docetaxel
75 mg/m2, IV, q 21 days, six 21 day cycles or progressive disease Drug: carboplatin AUC 6, IV, q 21 days, six 21 day cycles or progressive disease |
- Time to progressive disease [ Time Frame: baseline to measured progressive disease ]
- Assessment of biomarkers relevant to pemetrexed, carboplatin, enzastaurin, and disease state, and their correlation to clinical outcome [ Time Frame: baseline, cycle 1, cycle 2, end of study ]
- Assessment of smoking history and hormone replacement therapy and the correlation to clinical outcome [ Time Frame: baseline ]
- Comparisons of safety between each treatment arm [ Time Frame: every cycle ]
- Comparisons of patient reported outcomes using the FACT-Lung and FACT-Taxane [ Time Frame: every cycle ]
- Overall survival [ Time Frame: baseline to date of death from any cause ]
- Duration of response [ Time Frame: time of response to progressive disease ]
- Time to treatment failure [ Time Frame: baseline to stopping treatment ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- You must have been diagnosed with non-small cell lung cancer.
- You must be able to visit the doctor's office weekly during the active treatment period and as needed during the study follow-up period.
- You must be willing and able to swallow capsules.
- Your entry labs and medical tests must meet study requirements.
- You must be willing to have blood samples drawn and tissue samples obtained for gene and protein testing.
Exclusion Criteria:
- You have received radiation within 2 weeks of study enrollment.
- You have previously received any anti-cancer drug therapy for non-small cell lung cancer.
- You have an active infection or other serious condition.
- You take aspirin or aspirin-like medication regularly and are not able to stop taking them for a few days during each cycle of chemotherapy.
- You have recently lost a significant amount of weight.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308750
| United States, North Carolina | |
| 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. | |
| Burlington, North Carolina, United States, 27215 | |
| 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, 27599 | |
| United States, South Carolina | |
| 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. | |
| Columbia, South Carolina, United States, 29210 | |
| United States, Texas | |
| 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, 77060 | |
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00308750 |
| Other Study ID Numbers: |
10651 H6Q-US-S004 ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | March 30, 2006 Key Record Dates |
| Last Update Posted: | June 2, 2010 |
| Last Verified: | May 2010 |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Carboplatin |
Docetaxel Pemetrexed Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |