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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-US-S061 |
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Trial was stopped early due to low enrollment
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This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | baseline to measured progressive disease | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
| Time to Progressive Disease | Time to progressive disease not analyzed because trial was stopped early due to low enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Rochester | Minnesota | 55905 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 21-Day Cycle | Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles |
| FG001 | 14-Day Cycle | Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 21-Day Cycle | Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles |
| BG001 | 14-Day Cycle | Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best Overall Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. | Posted | Number | participants | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 21-Day Cycle | Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE | Systematic Assessment |
Trial was stopped early due to low enrollment. Some secondary outcomes were not analyzed due to the low numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Gemcitabine | Drug | A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles |
|
|
| baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
| Duration of Response | Duration of response was not analyzed because the trial was stopped early due to low enrollment. | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
| Time to Treatment Failure | Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment. | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
| Overall Survival | Survival time is defined as the time from date of randomization to death due to any cause. | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group Performance Score | Number | participants |
|
| Previous Radiation Therapy | Number | participants |
|
| Stage of Lung Cancer | Number | participants |
|
| Tumor Cell Type | Number | participants |
|
|
|
|
| Secondary | Progression Free Survival | baseline to measured progressive disease | Posted | Median | 95% Confidence Interval | months | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
|
|
|
| Secondary | Time to Progressive Disease | Time to progressive disease not analyzed because trial was stopped early due to low enrollment. | Posted | Median | 95% Confidence Interval | months | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
|
|
| Secondary | Duration of Response | Duration of response was not analyzed because the trial was stopped early due to low enrollment. | Posted | Median | 95% Confidence Interval | months | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
|
|
| Secondary | Time to Treatment Failure | Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment. | Posted | Median | 95% Confidence Interval | months | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
|
|
| Secondary | Overall Survival | Survival time is defined as the time from date of randomization to death due to any cause. | Posted | Median | 95% Confidence Interval | months | baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up |
|
|
|
|
| 9 |
| 10 |
| EG001 | 14-Day Cycle | Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles | 4 | 9 |
| Ischemia-Cerebral | Nervous system disorders | CTCAE | Systematic Assessment |
|
| Disease Progression - Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
|
| Pain - Extremity | General disorders | CTCAE | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
|
| Diarrhea-No Colostom | Gastrointestinal disorders | CTCAE | Systematic Assessment |
|
| Anorexia | Psychiatric disorders | CTCAE | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
|
| Pneumonia NOS | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
|
| Pruritis | Infections and infestations | CTCAE | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |