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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-US-JMGP |
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| Name | Class |
|---|---|
| Gynecologic Oncology Group | NETWORK |
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The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), through a vein in your arm. Vitamin supplementation is a required part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 900 mg/m2, intravenous (IV), 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. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria. | baseline to measured progressive disease (up to 44 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events by Grade | Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported. | every 21-day cycle up to 5 year follow-up |
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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 | Philadelphia | Pennsylvania |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed | Pemetrexed 900 mg/m2, intravenous (IV), 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, intravenous (IV), 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. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria. | Posted | Number | participants | baseline to measured progressive disease (up to 44 months) |
|
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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, intravenous (IV), every 21 days, until disease progression |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | 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 |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| 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 44 months) |
| Progression-Free Survival | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. | baseline until documented tumor progression (up to 44 months) |
| 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-year follow-up |
| United States |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cell Type | Number | participants |
|
| Gynecologic Oncology Group Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
|
| Prior Chemotherapy | Number | participants |
|
| Prior Radiotherapy | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Tumor Grade | Tumor grade is a system used to classify tumors based on certain characteristics of their cells. The grade is directly related to prognosis. The more they look like normal cells, the better the prognosis. Grades range from 1 (well-differentiated) to 4 (undifferentiated). The higher the grade, the worse the prognosis. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Adverse Events by Grade | Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported. | Posted | Number | participants | every 21-day cycle up to 5 year follow-up |
|
|
|
| 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. | Posted | Median | Full Range | months | time of initial response until documented tumor progression (up to 44 months) |
|
|
|
| Secondary | Progression-Free Survival | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. | Posted | Median | Full Range | months | baseline until documented tumor progression (up to 44 months) |
|
|
|
| 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-year follow-up |
|
|
|
| 12 |
| 48 |
| 47 |
| 48 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatinine abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular 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 |
|
| Neurologic | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Genitourinary | Renal and urinary 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 |
|
Not provided
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| 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 |
| Title | Measurements |
|---|---|
|
| Leukopenia - Grade 4 |
|
| Thrombocytopenia - Grade 1 |
|
| Thrombocytopenia - Grade 2 |
|
| Thrombocytopenia - Grade 3 |
|
| Thrombocytopenia - Grade 4 |
|
| Neutropenia - Grade 1 |
|
| Neutropenia - Grade 2 |
|
| Neutropenia - Grade 3 |
|
| Neutropenia - Grade 4 |
|
| Anemia - Grade 1 |
|
| Anemia - Grade 2 |
|
| Anemia - Grade 3 |
|
| Anemia - Grade 4 |
|
| Transfusion - Grade 1 |
|
| Transfusion - Grade 2 |
|
| Transfusion - Grade 3 |
|
| Transfusion - Grade 4 |
|
| Coagulation - Grade 1 |
|
| Coagulation - Grade 2 |
|
| Coagulation - Grade 3 |
|
| Coagulation - Grade 4 |
|
| Gastrointestinal - Grade 1 |
|
| Gastrointestinal - Grade 2 |
|
| Gastrointestinal - Grade 3 |
|
| Gastrointestinal - Grade 4 |
|
| Nausea/vomiting - Grade 1 |
|
| Nausea/vomiting - Grade 2 |
|
| Nausea/vomiting - Grade 3 |
|
| Nausea/vomiting - Grade 4 |
|
| Genitourinary - Grade 1 |
|
| Genitourinary - Grade 2 |
|
| Genitourinary - Grade 3 |
|
| Genitourinary - Grade 4 |
|
| Hepatic - Grade 1 |
|
| Hepatic - Grade 2 |
|
| Hepatic - Grade 3 |
|
| Hepatic - Grade 4 |
|
| Alopecia - Grade 1 |
|
| Alopecia - Grade 2 |
|
| Dermatologic - Grade 1 |
|
| Dermatologic - Grade 2 |
|
| Dermatologic - Grade 3 |
|
| Dermatologic - Grade 4 |
|
| Neurologic - Grade 1 |
|
| Neurologic - Grade 2 |
|
| Neurologic - Grade 3 |
|
| Neurologic - Grade 4 |
|
| SGOT - Grade 1 |
|
| SGOT - Grade 2 |
|
| SGOT - Grade 3 |
|
| SGOT - Grade 4 |
|
| Alkaline phosphatase - Grade 1 |
|
| Alkaline phosphatase - Grade 2 |
|
| Alkaline phosphatase - Grade 3 |
|
| Alkaline phosphatase - Grade 4 |
|
| Ocular - Grade 1 |
|
| Ocular - Grade 2 |
|
| Ocular - Grade 3 |
|
| Ocular - Grade 4 |
|
| Hemorrhage - Grade 1 |
|
| Hemorrhage - Grade 2 |
|
| Hemorrhage - Grade 3 |
|
| Hemorrhage - Grade 4 |
|
| Pulmonary - Grade 1 |
|
| Pulmonary - Grade 2 |
|
| Pulmonary - Grade 3 |
|
| Pulmonary - Grade 4 |
|
| Lymphopenia - Grade 1 |
|
| Lymphopenia - Grade 2 |
|
| Lymphopenia - Grade 3 |
|
| Lymphopenia - Grade 4 |
|
| Constitutional - Grade 1 |
|
| Constitutional - Grade 2 |
|
| Constitutional - Grade 3 |
|
| Constitutional - Grade 4 |
|
| Metabolic - Grade 1 |
|
| Metabolic - Grade 2 |
|
| Metabolic - Grade 3 |
|
| Metabolic - Grade 4 |
|
| Cardiovascular - Grade 1 |
|
| Cardiovascular - Grade 2 |
|
| Cardiovascular - Grade 3 |
|
| Cardiovascular - Grade 4 |
|
| Pain - Grade 1 |
|
| Pain - Grade 2 |
|
| Pain - Grade 3 |
|
| Pain - Grade 4 |
|
| Infection - Grade 1 |
|
| Infection - Grade 2 |
|
| Infection - Grade 3 |
|
| Infection - Grade 4 |
|
| Auditory - Grade 1 |
|
| Auditory - Grade 2 |
|
| Auditory - Grade 3 |
|
| Auditory - Grade 4 |
|
| Lymphatics - Grade 1 |
|
| Lymphatics - Grade 2 |
|
| Lymphatics - Grade 3 |
|
| Lymphatics - Grade 4 |
|
| Endocrine - Grade 1 |
|
| Endocrine - Grade 2 |
|
| Endocrine - Grade 3 |
|
| Endocrine - Grade 4 |
|
| Allergy - Grade 1 |
|
| Allergy - Grade 2 |
|
| Allergy - Grade 3 |
|
| Allergy - Grade 4 |
|