Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BB-IND 77,805 | Other Identifier | FDA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Sanofi | INDUSTRY |
| OSI Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer.
Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX, plus 5-FU and Erlotinib | Experimental | single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOX | Drug | Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib. | Per response evaluation criteria in solid tumors criteria (RECIST) for target lesions and assessed by computerized tomography (CT) scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions | 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | Adverse event assessment by investigators and as reported by subjects from time of consent to 30 days after last dose. Up to 3.5 years. | 3.5 years |
Not provided
Inclusion Criteria:
Metastatic or unresectable adenocarcinoma of the upper gastrointestinal tract that can be measured in at least one dimension according to RECIST criteria by CT or MRI
Gastric adenocarcinomas may be included if the primary tumor arises within 5 cm of the anatomic gastro-esophageal junction (distal esophagus) or from the gastric cardia as indicated by either endoscope or imaging.
Previously untreated with chemotherapeutic agents for unresectable or metastatic disease.
Adjuvant chemotherapy and/or radiotherapy are allowed as long as no oxaliplatin was used in the past 12 months.
ECOG performance status 0 or 1
Age > 18 years old.
Life expectancy greater than 6 months.
Peripheral neuropathy: must be < grade 1
Absolute neutrophil count > 1,500/mm3
Hemoglobin > 9.0 g/dl
Platelet count > 100,000/mm3
Hepatic Function:
Creatinine clearance of > 60 ml/min as calculated by the Cockcroft Gault formula. (Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) for males).
(Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) x 0.85 for females)
Women of childbearing potential must have a negative pregnancy test by urine or serum testing.
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 4 months after the last treatment.
Patients must have signed IRB approved informed consent
Patients must have the ability to comply with study and follow-up procedures.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zev Wainberg, MD | University of California, Los Angeles | Principal Investigator |
| Fairooz Kabbinavar, MD | UCLA - TORI | Study Director |
| J Randolph Hecht, MD | University of California, Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Oncology Research International (TORI) Network | Los Angeles | California | 90095 | United States | ||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FOLFOX Plus 5-FU and Erlotinib | FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 5-FU | Drug | 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. |
|
|
| Erlotinib | Drug | All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary. |
|
| UCLA Jonsson Comprehensive Cancer Center |
| Los Angeles |
| California |
| 90095 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
A total of 50 participants were screened for the study. A total of 12 participants were considered screening failures, 11 did not meet inclusion/exclusion criteria and 1 participant went to Hospice. Thirty eight participants were enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FOLFOX Plus 5-FU and Erlotinib | FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Eastern Cooperative Group performance status | ECOG score evaluated during exam by Physician. Runs from 0 to 5, with 0 denoting perfect health and 5 death. 0 - Asymptomatic
| Number | participants |
| ||||||||||||||||||||||
| Previous Treatment: Surgery | Number | participants |
| |||||||||||||||||||||||
| Previous Treatment Chemotherapy | Number | participants |
| |||||||||||||||||||||||
| Previous Chemotherapy Regimens | Number | participants |
| |||||||||||||||||||||||
| Previous radiation therapy | Number | participants |
| |||||||||||||||||||||||
| Neoadjuvant vs. Adjuvant Previous Radiation Therapy | Number | participants |
| |||||||||||||||||||||||
| Oesophagus vs. gastro-oesophageal junction | Number | 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 | Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib. | Per response evaluation criteria in solid tumors criteria (RECIST) for target lesions and assessed by computerized tomography (CT) scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions | 33 patients who were evaluable for response per protocol | Posted | Number | percent of subjects that had response | 3.5 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | Adverse event assessment by investigators and as reported by subjects from time of consent to 30 days after last dose. Up to 3.5 years. | Number of subjects that experienced Grade 3 and 4 Adverse events associated with FOLFOX/5-FU/Erlotinib therapy | Posted | Number | participants | 3.5 years |
|
|
consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary. | 1 | 38 | 7 | 38 | 38 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic Fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Sepsis associated with neutropenic fever (103°F), hypotension, dehydration, hyponatremia, intermittent gr. 2 diarrhea. |
|
| Septic Shock | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Nausea, vomiting, diarrhea, altered mental status, neutropenia with fever, septic shock, renal failure. Participant expired in hospital on 12/26/09. |
|
| Malnutrition | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Altered Mental State | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Inability to Urinate | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Intractable Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sacral Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Cranial Hematoma | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment | hematoma to head, small acute lacunar infarction. |
|
| Finger Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated International Normalized Ratio (INR) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| diskectomy | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment | Anterior cervical diskectomy for spinal cord decompression at C5-C6. Diskitis/osteomyelitis at C5-C6. Grade 3 tear of posterior horn of lateral meniscus and a moderate effusion. |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline Phosphatase - elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alanine Aminotransferase - elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase - elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bloating | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blood in stool | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cachexia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cerebrovascular accident (CVA) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cold sensitivity | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cold-like symptoms | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cramps - limbs | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine - elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diabetes mellitus | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diaphoresis | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eye | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry heaves | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry Nose | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspepsia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Facial flushing | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flu-like syndrome | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Folliculitis | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gait-Walking | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GERD | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glossitis | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hand and Foot Syndrome | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heart burn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage (GI, gums, nose, upper GI) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage (nose, oral cavity) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoid | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccups | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flashes | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperalbuminemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercholesterolemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypothermia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | GI NOS, paronychia, picc line, sinus, skin, skin fungal, ungual, cellulitis, upper airway NOS, urinary tract NOS, J-tube site |
|
| Infection (skin, upper airway, pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| International Normalized Ratio (INR) - elevated | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint effusion - Elbow | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lactose intolerance | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mental status | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - anxiety | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - depression | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis - oral cavity | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myotonia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail Changes | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy - motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy - sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenic fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Night sweats | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction - GI small bowel NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular - drainage | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular - ruptured vessel | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Odynophagia | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment | abdomen, around J-tube, back, buttock, chest, epigastric, flank, hip, knee, limbs, neck, NOS, rib, shoulder, stomach, throat, right upper quadrant |
|
| Pallor | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Palpitation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Perforation gastrointestinal tract | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Performance Status Decrease | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | limbs, chest, scalp, portacath site, facial |
|
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rhinitis | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors-Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Serum Chloride - Decrease | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Serum Protein - Decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinusitis | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation - portacath site | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin Irritation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | picc line site |
|
| Papule lower extremities | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Papule upper chest | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin abrasion | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stomatitis | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis-Embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zev Wainberg, MD | UCLA GI Oncology Program, David Geffen School of Medicine at UCLA | 310-829-5471 | zwainberg@mednet.ucla.edu |
| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
Not provided
Not provided
| Title |
|---|
| Measurements |
|---|
|
| Epirubicin/cisplatin/5-FU |
|
| None |
|
| None |
|
|