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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00078095 [JHMIRB] |
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Purpose:
The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded with irinotecan (DEBIRI-M1), and used to administer transarterial chemoembolization (TACE).
Eligibility:
Patients with liver cancer from colorectal cancer.
Study Overview/ Treatment:
DEBIRI, loaded with irinotecan, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of irinotecan into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive DEBIRI, should it be recommended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEBIRI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEBIRI | Drug | Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| Success of DEBIRI-M1 Procedure as a Measure of Feasibility (Percentage of Successful Treatments) | Feasibility is defined as achieving an acceptable level of technical success in the use of DEBIRI beads treating hepatic metastases in patients with colorectal cancer. | 6 months |
| Safety, Defined as Demonstrating Tolerable Device-related Toxicity Profile in the Use of DEBIRI Beads Used to Treat Hepatic Metastases in Patients With Colorectal Cancer | Toxicities assessed as being at least possibly related will be recorded including system organ class, subclass, grade, frequency and time interval from DEBIRI-M1. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Tumor Response by RECIST | Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6-week imaging following TACE treatments. Complete Response (CR): Disappearance of all lesions targeted by DEBIRI-M1 Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of lesions targeted by DEBIRI-M1, taking as reference the baseline sum LD Progressive Disease (PD): At least 20% increase in sum of the LD Of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD since treatment started |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint - Pharmacokinetic (PK) Profile of Irinotecan and SN-38 Post DEBIRI-TACE | PK analysis of irinotecan and its metabolite SN-38 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax). Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan. | 24 hours |
Inclusion Criteria:
-Patients with a diagnosis of colorectal cancer with hepatic metastases who have failed or are intolerant to at least one systemic chemotherapy or liver directed therapy.
The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.
The patient is age 18 years or older.
The patient has a life expectancy of >12 weeks.
Patients with liver dominant disease defined as >/=75% tumor body burden confined to the liver
Less than 60% liver tumor replacement
At least one month has elapsed since most recent prior cancer therapy with the following exception:
-Chemotherapy (excluding irinotecan based regimens) may continue if there is evidence of hepatic progression on treatment providing there is no change in the therapy in the 1 month prior to DEBIRI-TACE treatment and any immediate chemotherapeutic toxicity that will complicate DEBIRI-TACE is resolved. In this case, the chemotherapy may continue because it is continuing to control the extrahepatic disease.
The patient has measurable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
Patients with at least one measurable liver metastases> 2 cm.
Patients with patent main portal vein
The patient has adequate hematologic function as defined by the following criteria:
-An absolute neutrophil count (ANC) >/= 1500/mL, Hemoglobin >/= 9.5 g/dL, and a Platelet count >/=75,000/mL, INR </=1.3 prior to receiving DEBIRI-TACE.
The patient has adequate hepatic function, as defined by the following criteria:
-Total bilirubin</= 2.0 mg/dL, Aspartate transaminase (AST) and alanine transaminase (ALT) </= 5 x the upper limit of normal (ULN), Albumin >2.
The patient has adequate renal function, as defined by the following criteria:
-Serum creatinine</=2.0.
The patient has a baseline international normalized ratio (INR)<1.5.
The patient, if a woman of childbearing potential, has a negative pregnancy test.
The patient is able to give written informed consent.
The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans.
Exclusion Criteria:
The patient has a history of another primary cancer (ie, a primary cancer not associated with the patient's current liver tumor), with the exception of (a) curatively resected nonmelanomatous skin cancer; (b) curatively treated cervical carcinoma in situ; or (c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to enrollment (date of informed consent).
Any contraindication for hepatic embolization procedures:
Contraindications to irinotecan:
The patient has untreatable bleeding diathesis.
The patient has complete main portal vein thrombosis with reversal of flow.
The patient has evidence of clinically significant peripheral vascular disease.
The patient has brain metastases
The patient has clinically significant or symptomatic extrahepatic disease, for example, an uncontrolled intercurrent illness including, but not limited to:
The patient is pregnant or breast-feeding.
Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
There is evidence of substance abuse or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results
The patient is allergic to contrast media that cannot be readily prevented with premedication or managed.
Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation
The patient has peritoneal disease or ascites (greater than trace on imaging).
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| Name | Affiliation | Role |
|---|---|---|
| J.F. Geschwind, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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This study enrolled patients diagnosed with colorectal cancer with unresectable hepatic metastases who have failed or were intolerant to at least one line of systemic chemotherapy or liver-directed therapy. Patients were enrolled at Johns Hopkins to receive transarterial chemoembolization (TACE) therapy. The last patient completed in June 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | DEBIRI | DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor. LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer. TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DEBIRI | DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor. LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer. TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply. |
| 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 | Success of DEBIRI-M1 Procedure as a Measure of Feasibility (Percentage of Successful Treatments) | Feasibility is defined as achieving an acceptable level of technical success in the use of DEBIRI beads treating hepatic metastases in patients with colorectal cancer. | The 14 patients received a total of 32 DEBIRI-M1 TACE procedures. | Posted | Number | percentage of successful treatments | 6 months | DEBIRI-M1 Treatments | DEBIRI-M1 Treatments |
|
Adverse events collected through study completion, an average of 6 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 | DEBIRI | DEBIRI: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor. LC Bead M1: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer. TACE: TACE a minimally invasive procedure performed to restrict a tumor's blood supply. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Francois Geschwind, MD | Yale University | 203-785-5865 | jeff.geschwind@yale.edu |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| LC Bead M1 | Device | The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer. |
|
| TACE | Procedure | TACE a minimally invasive procedure performed to restrict a tumor's blood supply. |
|
| 24 weeks |
| Efficacy - Tumor Response by mRECIST | Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 6-week imaging following TACE treatments. Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started. Stable Disease (SD): Any cases that do not qualify for either PR or PD. | 24 weeks |
| Efficacy -Tumor Response by European Association for the Study of the Liver (EASL) Criteria | Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 6-week imaging following TACE treatments. Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBIRI-M1. Baseline degree of tumor enhancement used as a reference. Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBIRI-M1. Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBIRI-M1. Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBIRI-M1. | 24 weeks |
| Efficacy - Tumor Response by World Health Organization (WHO) Criteria | Efficacy as assessed by radiographic tumor response using WHO criteria at baseline and at 6-week imaging following TACE treatments. Complete Response (CR): No lesions detected for at least 4 weeks. Partial Response (PR): 50% or greater decrease in the sum of the products of diameters Stable Disease (SD): Cases that do not fit the criteria of PR or PD. Progressive Disease (PD): 25% or greater increase in the sum of the products of diameters in one or more lesions; or new lesions | 24 weeks |
| Number of Participants With Change in Carcinoembryonic Antigen (CEA) | CEA measurements pre- and post- DEBIRI treatment will be recorded to ascertain if it is predictive of survival. | 6 weeks |
| Median Overall Survival | Median overall survival from start of therapy (DEBIRI #1) until death (or date of censor). | Up to 26 months |
| One-year Survival Percentage | Percentage of study patients surviving after one year from initial treatment analyzed with Kaplan-Meier curve. | 1 year |
| Exploratory Endpoint -Total Drug Exposure Over Time (AUC) of Irinotecan and SN-38 Post DEBIRI-TACE | Total drug exposure over time (AUC) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan. | 24 hours |
| Exploratory Endpoint -Tmax of Irinotecan and SN-38 Post DEBIRI-TACE | Time taken to reach maximum concentration (Tmax) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan. | 24 hours |
| Plasma Half-life of Irinotecan and SN-38 Post DEBIRI-TACE | Plasma half-life (t 1/2) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan. | 24 hours |
| Exploratory Endpoint - Angiogenesis | Changes in vascular endothelial growth factors (VEGF), VEGF receptors VEGFR1 and VEGFR2 pre- and post- DEBIRI treatment examined for significant effects as well as association with DEBIRI treatment. One-sample Wilcoxon signed rank test was utilized to compare whether %change of VEGF, VEGFR1, or VEGFR2 from baseline was equal to 0. For groups with non-zero percent changes, the 95% confidence intervals were provided. | 24 hours |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Out of 14 enrolled participants, 10 participants identified as non-Hispanic and 4 patients did not elect to reveal their ethnicity. From the 14 participants, 9 were white, 4 were black or African American, and 1 was unknown. | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Safety, Defined as Demonstrating Tolerable Device-related Toxicity Profile in the Use of DEBIRI Beads Used to Treat Hepatic Metastases in Patients With Colorectal Cancer | Toxicities assessed as being at least possibly related will be recorded including system organ class, subclass, grade, frequency and time interval from DEBIRI-M1. | 6-week toxicity report of device-related adverse events for all 14 participants. Classification and grading based on CTCAE v4.0. | Posted | Count of Participants | Participants | No | 6 weeks |
|
|
|
| Secondary | Efficacy - Tumor Response by RECIST | Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6-week imaging following TACE treatments. Complete Response (CR): Disappearance of all lesions targeted by DEBIRI-M1 Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of lesions targeted by DEBIRI-M1, taking as reference the baseline sum LD Progressive Disease (PD): At least 20% increase in sum of the LD Of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD since treatment started | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Efficacy - Tumor Response by mRECIST | Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 6-week imaging following TACE treatments. Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started. Stable Disease (SD): Any cases that do not qualify for either PR or PD. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Efficacy -Tumor Response by European Association for the Study of the Liver (EASL) Criteria | Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 6-week imaging following TACE treatments. Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBIRI-M1. Baseline degree of tumor enhancement used as a reference. Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBIRI-M1. Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBIRI-M1. Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBIRI-M1. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Efficacy - Tumor Response by World Health Organization (WHO) Criteria | Efficacy as assessed by radiographic tumor response using WHO criteria at baseline and at 6-week imaging following TACE treatments. Complete Response (CR): No lesions detected for at least 4 weeks. Partial Response (PR): 50% or greater decrease in the sum of the products of diameters Stable Disease (SD): Cases that do not fit the criteria of PR or PD. Progressive Disease (PD): 25% or greater increase in the sum of the products of diameters in one or more lesions; or new lesions | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Number of Participants With Change in Carcinoembryonic Antigen (CEA) | CEA measurements pre- and post- DEBIRI treatment will be recorded to ascertain if it is predictive of survival. | 2 out of original 14 patients had no CEA measurements. | Posted | Number | participants | 6 weeks |
|
|
|
|
| Secondary | Median Overall Survival | Median overall survival from start of therapy (DEBIRI #1) until death (or date of censor). | Posted | Median | Full Range | months | Up to 26 months |
|
|
|
| Secondary | One-year Survival Percentage | Percentage of study patients surviving after one year from initial treatment analyzed with Kaplan-Meier curve. | Posted | Number | percentage of participants | 1 year |
|
|
|
| Other Pre-specified | Exploratory Endpoint - Pharmacokinetic (PK) Profile of Irinotecan and SN-38 Post DEBIRI-TACE | PK analysis of irinotecan and its metabolite SN-38 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax). Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan. | Posted | Median | Standard Deviation | ng/mL | 24 hours |
|
|
|
| Other Pre-specified | Exploratory Endpoint -Total Drug Exposure Over Time (AUC) of Irinotecan and SN-38 Post DEBIRI-TACE | Total drug exposure over time (AUC) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan. | Posted | Mean | Standard Deviation | ng*h/mL | 24 hours |
|
|
|
| Other Pre-specified | Exploratory Endpoint -Tmax of Irinotecan and SN-38 Post DEBIRI-TACE | Time taken to reach maximum concentration (Tmax) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan. | Posted | Median | Standard Deviation | hours | 24 hours |
|
|
|
| Other Pre-specified | Plasma Half-life of Irinotecan and SN-38 Post DEBIRI-TACE | Plasma half-life (t 1/2) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan. | Posted | Median | Standard Deviation | hours | 24 hours |
|
|
|
| Other Pre-specified | Exploratory Endpoint - Angiogenesis | Changes in vascular endothelial growth factors (VEGF), VEGF receptors VEGFR1 and VEGFR2 pre- and post- DEBIRI treatment examined for significant effects as well as association with DEBIRI treatment. One-sample Wilcoxon signed rank test was utilized to compare whether %change of VEGF, VEGFR1, or VEGFR2 from baseline was equal to 0. For groups with non-zero percent changes, the 95% confidence intervals were provided. | Posted | Median | 95% Confidence Interval | % change from baseline | 24 hours |
|
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 14 |
| 14 |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Concentration impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Anemia |
|
| Nausea |
|
| Leukopenia |
|
| 30-day mortality |
|
| Participants with no events |
|
| Grade 3-4 Adverse Events |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Objective response (CR + PR) |
|
| Disease control rate (CR + PR + SD) |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Objective response (CR + PR) |
|
| Disease control rate (CR + PR + SD) |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Objective response (CR + PR) |
|
| Disease control rate (CR + PR + SD) |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Objective response (CR + PR) |
|
| Disease control rate (CR + PR + SD) |
|
|
| VEGFR1 (24 hours post) |
|
| VEGFR2 (immediately post) |
|
| VEGFR2 (24 hours post) |
|
| Other |
VEGF at 24 hours post treatment. |
| one-sample Wilcoxon signed rank test | 0.583 | Other | VEGFR1 immediately post treatment. |
| one-sample Wilcoxon signed rank test | .0012 | Other | VEGFR1 at 24 hours post treatment. |
| one-sample Wilcoxon signed rank test | 0.1353 | Other | VEGFR2 immediately post treatment. |
| one-sample Wilcoxon signed rank test | 0.2163 | Other | VEGFR2 at 24 hours post treatment. |