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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-ES-S085 | Other Identifier | Eli Lilly and Company |
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To assess the anti-tumor activity, as measured by response rate to bi-weekly pemetrexed plus cisplatin, in chemo-naive patients with diagnosed metastatic or locally advanced (non-resectable) urothelial cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed + Cisplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | Phase 1: 300 mg/m^2, intravenous (IV), days 1 and 15 every 28 days x 2 cycles (dose escalation: 300 mg/m^2, 400 mg/m^2, and 500 mg/m^2) Phase 2: phase 1 determined dose, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy |
| 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. 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 620 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response | Defined as time from study enrollment to the first Complete Response or Partial Response (using RECIST criteria). Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. | baseline to response (up to 620 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) 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. | Barcelona | 08035 |
A total of 59 participants entered the trial (21 in Phase 1 and 38 in Phase 2). Phase 1 determined the dose for Phase 2 to be 400 mg/m^2. Phase 2 results are reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed + Cisplatin | Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed + Cisplatin | Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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. 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 620 days) |
|
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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 + Cisplatin | Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | 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 | 800-545-5979 |
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| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
|
| cisplatin | Drug | Phase 1: 50 mg/m^2, intravenous (IV), days 1 and 15 every 28 days x 2 cycles Phase 2: 50 mg/m^2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy |
|
| 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. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. |
| time of response to progressive disease (up to 620 days) |
| Duration of Stable Disease | Defined as time from study enrollment to the first progression of disease, complete response, partial response, or death from any cause. 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. | time of no response or progression (up to 620 days) |
| Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. | baseline to measured progressive disease (up to 620 days) |
| Time to Treatment Failure (TTF) | Time from study enrollment to first observation of disease progression, death from any cause, or early discontinuation of treatment (including toxicity or if patient had stable disease after 4 cycles). TTF was censored at date of last follow-up visit for patients who did not discontinue early, who were still alive, and who had not progressed. | baseline to stopping treatment (up to 620 days) |
| Progression-Free Survival | Defined as the time from study enrollment until disease progression or death from any cause. | baseline to measured progressive disease (up to 620 days) |
| 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 to date of death from any cause (up to 620 days) |
| Spain |
| 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. | Madrid | 28041 | Spain |
| 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. | Pamplona | 31008 | Spain |
| 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. | Sabadell | 08208 | Spain |
| 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. | Santander | 39008 | Spain |
| Lost to Follow-up |
|
| Death |
|
| Other - Not Specified |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
|
| Location of Primary Tumor | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
|
|
| Secondary | Time to Response | Defined as time from study enrollment to the first Complete Response or Partial Response (using RECIST criteria). Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. | 16 patients were censored. | Posted | Mean | Standard Error | days | baseline to response (up to 620 days) |
|
|
|
| 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. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. | 10 patients were censored. | Posted | Mean | Standard Error | days | time of response to progressive disease (up to 620 days) |
|
|
|
| Secondary | Duration of Stable Disease | Defined as time from study enrollment to the first progression of disease, complete response, partial response, or death from any cause. 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. | 1 patient was censored. | Posted | Median | 95% Confidence Interval | days | time of no response or progression (up to 620 days) |
|
|
|
| Secondary | Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. | 19 patients were censored | Posted | Mean | Standard Error | days | baseline to measured progressive disease (up to 620 days) |
|
|
|
| Secondary | Time to Treatment Failure (TTF) | Time from study enrollment to first observation of disease progression, death from any cause, or early discontinuation of treatment (including toxicity or if patient had stable disease after 4 cycles). TTF was censored at date of last follow-up visit for patients who did not discontinue early, who were still alive, and who had not progressed. | 1 patient was censored | Posted | Median | 95% Confidence Interval | days | baseline to stopping treatment (up to 620 days) |
|
|
|
| Secondary | Progression-Free Survival | Defined as the time from study enrollment until disease progression or death from any cause. | 11 patients were censored | Posted | Median | 95% Confidence Interval | days | baseline to measured progressive disease (up to 620 days) |
|
|
|
| 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. | 20 patients were censored. | Posted | Mean | Standard Error | days | baseline to date of death from any cause (up to 620 days) |
|
|
|
| 16 |
| 38 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Leukopenia | 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 |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Blood electrolytes abnormal | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular 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 |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |