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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-US-JMGS |
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| Name | Class |
|---|---|
| Gynecologic Oncology Group | NETWORK |
This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 to measured progressive disease (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | time of initial response until documented tumor progression (up to 5 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Miller, MD | Gynecologic Oncology Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group 215-854-0770 | Philadelphia | Pennsylvania | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed | Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed | Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | 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 to measured progressive disease (up to 5 years) |
|
|
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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 | Pemetrexed | Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Progression-Free Survival |
The period from study entry until disease progression, death or date of last contact. |
| baseline until documented tumor progression (up to 5 years) |
| Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | baseline until death from any cause (up to 5 years) |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Cell Type | Number | participants |
|
| Gynecologic Oncology Group (GOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
|
| Prior Therapy | Number | participants |
|
| Tumor Grade | Assesses the extent to which cancer cells are similar in appearance and function to healthy cells of the same tissue type. Grades range from 1 (least aggressive and best prognosis) to 4 (most aggressive and worst prognosis). | Number | participants |
|
|
|
| Secondary | Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | All enrolled participants who had either a complete response (n=0) or partial response (n=4). | Posted | Median | Full Range | months | time of initial response until documented tumor progression (up to 5 years) |
|
|
|
| Secondary | Progression-Free Survival | The period from study entry until disease progression, death or date of last contact. | All enrolled participants who experienced disease progression. | Posted | Median | Full Range | months | baseline until documented tumor progression (up to 5 years) |
|
|
|
| Secondary | Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | Posted | Median | Full Range | months | baseline until death from any cause (up to 5 years) |
|
|
|
| 5 |
| 27 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Lymphatics | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiovascular | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Auditory | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ocular | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea/vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constitutional | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hepatic | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Serum glutamic oxaloacetic transaminase | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Metabolic | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dermatologic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |