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| ID | Type | Description | Link |
|---|---|---|---|
| J14161 | Other Identifier | Swim Across America Laboratory | |
| IRB00053208 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Swim Across America | OTHER |
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This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.
The study is being done in 2 parts. The first part is the dose escalation (Phase I) part of the study where the dose of irinotecan is increased until the highest safe dose of irinotecan is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin.
After the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and cisplatin is defined, the second part of the study (Phase 2) will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 - Phase 1 | Experimental |
|
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| Dose Level 2 - Phase 1 | Experimental |
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| Dose Level 3 - Phase 1 | Experimental |
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| Dose Level 1a - Phase 1 | Experimental |
|
|
| Dose level 1b - Phase 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | IV on days 4 and 11 of a 21 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Gemcitabine | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. | 28 days |
| Maximum Tolerated Dose (MTD) of Docetaxel | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. | 28 days |
| Maximum Tolerated Dose (MTD) of Capecitabine | Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. | 28 days |
| Maximum Tolerated Dose (MTD) of Cisplatin | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. | 28 days |
| Maximum Tolerated Dose (MTD) of Irinotecan | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. | 28 days |
| Overall Survival (OS) Rate at 9 Months | OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (RR) Using RECIST 1.1 Criteria | RR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dung Le, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36970054 | Derived | Christenson ES, Lim SJ, Durham J, De Jesus-Acosta A, Bever K, Laheru D, Ryan A, Agarwal P, Scharpf RB, Le DT, Wang H. Cell-free DNA Predicts Prolonged Response to Multi-agent Chemotherapy in Pancreatic Ductal Adenocarcinoma. Cancer Res Commun. 2022 Nov 11;2(11):1418-1425. doi: 10.1158/2767-9764.CRC-22-0343. eCollection 2022 Nov. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1- Phase 1 | Gemcitabine: 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2019 |
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| Experimental |
|
|
| Phase 2 | Experimental |
|
|
|
| Taxotere | Drug | IV on days 4 and 11 of a 21 day cycle |
|
|
| Xeloda | Drug | Twice a day orally on days 1 through 14 of a 21 day cycle |
|
|
| Cisplatin | Drug | IV on days 4 and 11 of a 21 day cycle |
|
|
| Irinotecan | Drug | IV on days 4 and 11 of a 21 day cycle |
|
|
| 43 months |
| Disease Control Rate (DCR) Using RECIST 1.1 Criteria | DCR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | 43 months |
| Progression-free Survival (PFS) Using RECIST 1.1 Criteria | PFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. | 5 years |
| Overall Survival (OS) | OS will be measured (in months) from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. | 5 years |
| FG001 |
| Dose Level 1a - Phase 1 |
Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| FG002 | Dose Level 1b - Phase 1 | Gemcitabine - 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| FG003 | Dose Level 2 - Phase 1 | Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin -15 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| FG004 | Dose Level 3 - Phase 1 | Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin - 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 60 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| FG005 | Phase 2 | Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 - Phase 1 | Gemcitabine: 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| BG001 | Dose Level 1a - Phase 1 | Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| BG002 | Dose Level 1b - Phase 1 | Gemcitabine - 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| BG003 | Dose Level 2 - Phase 1 | Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin -15 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| BG004 | Dose Level 3 - Phase 1 | Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin - 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 60 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| BG005 | Phase 2 | Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Maximum Tolerated Dose (MTD) of Gemcitabine | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. | Posted | Number | mg/m^2 | 28 days |
|
|
| |||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) of Docetaxel | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. | Posted | Number | mg/m^2 | 28 days |
|
| ||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) of Capecitabine | Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. | Posted | Number | mg | 28 days |
|
| ||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) of Cisplatin | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. | Posted | Number | mg/m^2 | 28 days |
|
| ||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) of Irinotecan | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. | Posted | Number | mg/m^2 | 28 days |
|
| ||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) Rate at 9 Months | OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only) | This measure was only assessed for Phase 2. Per protocol, the 6 subjects treated at the MTD (DL1a) during dose escalation (Phase 1) were counted toward the total sample size of 30 subjects for the Phase 2 outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 9 months |
|
| ||||||||||||||||||||||||||
| Secondary | Response Rate (RR) Using RECIST 1.1 Criteria | RR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | Posted | Number | 95% Confidence Interval | percentage of participants | 43 months |
|
| |||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) Using RECIST 1.1 Criteria | DCR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | Posted | Number | 95% Confidence Interval | percentage of participants | 43 months |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Using RECIST 1.1 Criteria | PFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. | Posted | Median | 95% Confidence Interval | Months | 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS will be measured (in months) from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. | Posted | Median | 95% Confidence Interval | Months | 5 years |
|
|
All adverse events will be collected from the first dose up to 30 days after last dose.
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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 | Dose Level 1 - Phase 1 | Gemcitabine: 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle | 2 | 6 | 0 | 6 | 6 | 6 |
| EG001 | Dose Level 1a - Phase 1 | Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle | 1 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Dose Level 1b - Phase 1 | Gemcitabine - 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle | 0 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Dose Level 2 - Phase 1 | Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin -15 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 40 mg/m^2 IV on days 4 and 11 of a 21 day cycle | 0 | 4 | 2 | 4 | 4 | 4 |
| EG004 | Dose Level 3 - Phase 1 | Gemcitabine - 400 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin - 15 mg/m^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 60 mg/m^2 IV on days 4 and 11 of a 21 day cycle | 0 | 4 | 1 | 4 | 4 | 4 |
| EG005 | Phase 2 | Gemcitabine: 500 mg/m^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 20 mg/m^2 IV on Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2 IV on days 4 and 11 of a 21 day cycle | 0 | 24 | 2 | 24 | 24 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Acute Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Leukoencephalopathy | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Edema | General disorders | Systematic Assessment | and administration site conditions |
| |
| Fatigue | General disorders | Systematic Assessment | and administration site conditions |
| |
| Fever | General disorders | Systematic Assessment | and administration site conditions |
| |
| Sweating | General disorders | Systematic Assessment | and administration site conditions |
| |
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Creatinine, increased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Weight Loss | Investigations | Systematic Assessment |
| ||
| White blood count decreased | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nail discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Phlebitis | Vascular disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cold Intolerance | General disorders | Systematic Assessment | and administration site conditions |
| |
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Leukoencephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Memory impairment | Nervous system disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nail changes | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Blurred vision | Eye disorders | Systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Systematic Assessment |
| ||
| Early satiety | Gastrointestinal disorders | Systematic Assessment |
| ||
| Muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nail Loss | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Systematic Assessment |
| ||
| Nail ridging | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nocturia | Renal and urinary disorders | Systematic Assessment |
| ||
| Tooth sensitivity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight gain | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dung Le, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | 443-287-0002 | dle@jhmi.edu |
| Jun 24, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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