Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. This study is being done to find out how long it takes tumors to grow after patients receive the drugs capecitabine, oxaliplatin and bevacizumab. Capecitabine (also called Xeloda) is a drug that has been approved by the FDA for treatment of advanced colorectal cancer. Capecitabine prevents some colorectal cancer cancer cells from reproducing, and causes some of them to die. Oxaliplatin (also called Eloxatin) has also been approved by the FDA for treatment of advanced colorectal cancer. Oxaliplatin prevents some colorectal cancer cells from reproducing. Bevacizumab is an investigational drug. Bevacizumab is an antibody (a protein that acts against a specific substance) directed against vascular endothelial growth factor (VEGF). VEGF promotes the growth of blood vessels that bring nutrients to cells. Bevacizumab inhibits the growth of colon cancer cells, by blocking the effects of VEGF. The combination of the drugs used in this study is experimental. The purpose of this study is to see how long it takes patients' tumors to grow when they are taking this combination of drugs.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaliplatin, followed by Bevacizumab with Capecitabine | Experimental | oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time for Progression Free Survival | Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first. | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 or Higher Toxicity | Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom. | Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating woman.
Life expectancy < 3 months.
Serious, uncontrolled, concurrent infection(s) or illness(es)
Any prior oxaliplatin treatment, with the exception of adjuvant therapy given > 12 months prior to the beginning of study therapy
Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-fluorouracil, or known DPD deficiency
Prior unanticipated severe reaction or hypersensitivity to platinum based compounds.
Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
Current, recent (within 4 weeks of first infusion on this study) or planned participation in an investigational drug study.
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months.
History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
History of persistent neurosensory disorder including but not limited to peripheral neuropathy.
Presence of central nervous system or brain mets.
Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Any of the following laboratory values:
Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
Blood pressure > 150/100 mmHg
Unstable angina
New York Heart Association (NYHA) Grade II or greater congestive heart failure
History of myocardial infarction or stroke within 6 months
Clinically significant peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0.
Serious, non-healing wound, ulcer or bone fracture
Carcinoma of any histology in close proximity to a major vessel, cavitation or history of hemoptysis.
Completion of previous adjuvant chemotherapy regimen < four weeks prior to the start of study treatment (within six weeks of study treatment for mitomycin C and nitroureas), or with related toxicities unresolved prior to the start of study treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Syma Iqbal, M.D. | U.S.C. Norris Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S.C./Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22622147 | Derived | Hurwitz H, Mitchell EP, Cartwright T, Kwok A, Hu S, McKenna E, Patt YZ. A randomized, phase II trial of standard triweekly compared with dose-dense biweekly capecitabine plus oxaliplatin plus bevacizumab as first-line treatment for metastatic colorectal cancer: XELOX-A-DVS (dense versus standard). Oncologist. 2012;17(7):937-46. doi: 10.1634/theoncologist.2012-0071. Epub 2012 May 23. |
Not provided
Not provided
This trial has no pre-assignment. All subjects were given the same treatment.
Recruitment for this trial opened in February 2005 and closed in May 2009. All subjects were seen at USC.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Oxaliplatin Followed by Bevacizumab, With Capecitabine | oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All the participants who were enrolled are included in the analysis as per protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oxaliplatin Followed by Bevacizumab, With Capecitabine | oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily |
| 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 |
| 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 | Median Time for Progression Free Survival | Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first. | All enrolled participants who receive the first course of treatment are included in the analysis as per protocol. | Posted | Median | 95% Confidence Interval | Months | Up to 6 years |
|
Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Not provided
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 | Oxaliplatin Followed by Bevacizumab, With Capecitabine | oxaliplatin 85/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Soto, Project Specialist | USC Norris Comprehensive Cancer Center | 323-226-6384 | victoria.soto@med.usc.edu |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bevacizumab |
| Drug |
|
|
| Capecitabine | Drug |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Grade 3 or Higher Toxicity | Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom. | All enrolled participants who receive the first course of treatment are included in the analysis as per protocol. | Posted | Number | Participants | Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months. |
|
|
|
| 51 |
| 63 |
| 63 |
| 63 |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Colitis, infectious | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Death not associated with CTCAE term (Death NOS) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Distension/bloating, abdominal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia (fever, unknown origin w/o clinically or microbiologically documented infection) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GI (colon) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection with unknown ANC (Wound) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Lipase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Obstruction, GU (Ureter) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (Abdomen NOS) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (Bone) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (Rectum) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Amylase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: limb | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever (in absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hail loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GI (Anus) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GI (Oral cavity) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GI (Rectum) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GI (Upper GI NOS) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GU (Urinary NOS) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, pulmonary/upper respiratory (Nose) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| INR (International Normalized Ratio of prothrombin time) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration (Depression) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis/stomatitis (Oral cavity) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Pain (Abdomen NOS) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (Back) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (Chest/thorax NOS) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (Head/headache) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (Muscle) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (Rectum) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/embolism (vascular access-related) | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Wound complication, non-infectious | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |