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Enrollment closed 10/15/2008 based on data about KRAS.
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The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.
Research has shown that the more drug treatments patients with cancer of the colon or rectum receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all patients on this study will receive. Bevacizumab is an antibody which blocks blood flow to tumors and increases how long patients with colorectal cancer live. However, it can increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with bevacizumab. One goal of this study is to find out the response rate (chance of tumor shrinking) with two treatments for colorectal cancer. All patients will get capecitabine, oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are approved to treat colorectal cancer. This research study is being done to find the best, safest way to combine these therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab | Active Comparator | Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle |
|
| Cetuximab, Oxaliplatin, Capecitabine | Active Comparator | Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate calculated by the proportion of overall response: CR+PR. Patients were categorized by one of the following (1-4 per RECISTv1.0 criteria on CT, MRI, x-ray; 4-9 considered failure to respond/disease progression):
9) unknown (not assessable, insufficient data) | every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0) assessed by CT, MRI, x-ray scan: Complete response (CR): Disappearance of all lesions Partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL Stable disease (SD): Neither PR, PD, or CR Progressive disease (PD): >=20% increase in the SoL; from smallest SoL. Or appearance of new lesion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Cohen, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22294255 | Result | Dotan E, Meropol NJ, Burtness B, Denlinger CS, Lee J, Mintzer D, Zhu F, Ruth K, Tuttle H, Sylvester J, Cohen SJ. A phase II study of capecitabine, oxaliplatin, and cetuximab with or without bevacizumab as frontline therapy for metastatic colorectal cancer. A Fox Chase extramural research study. J Gastrointest Cancer. 2012 Dec;43(4):562-9. doi: 10.1007/s12029-012-9368-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab | Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle |
| FG001 | Cetuximab, Oxaliplatin, Capecitabine | Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab | Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle |
| BG001 |
| 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 | Objective Response Rate (ORR) | Objective response rate calculated by the proportion of overall response: CR+PR. Patients were categorized by one of the following (1-4 per RECISTv1.0 criteria on CT, MRI, x-ray; 4-9 considered failure to respond/disease progression):
9) unknown (not assessable, insufficient data) | One patient in Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab Arm was not evaluable for response due to patient discontinuing after experiencing a hypersensitivity reaction to cetuximab during the first treatment. | Posted | Count of Participants | Participants | every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19) |
|
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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 | Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab | Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity reaction | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Cohen | Fox Chase Cancer Center | 215-214-1676 | steven.cohen@fccc.edu |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000068818 | Cetuximab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| cetuximab | Drug | Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle |
|
|
| Oxaliplatin | Drug | Oxaliplatin 130mg/m2 IV day 1 every 21 days |
|
|
| Capecitabine | Drug | Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle |
|
|
| every 6-9 weeks; from dose of first study drug to event |
| Overall Survival | Follow-up for survival to be done at 3 month intervals for 2 years, then 6 month intervals for up to 5 years from study registration | From dose of first study drug to last timepoint known to be alive (median follow-up for all patients was 25.9 months) |
| Cetuximab, Oxaliplatin, Capecitabine |
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 | Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab | Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle |
| OG001 | Cetuximab, Oxaliplatin, Capecitabine | Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle |
|
|
| Secondary | Time to Progression (TTP) | Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0) assessed by CT, MRI, x-ray scan: Complete response (CR): Disappearance of all lesions Partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL Stable disease (SD): Neither PR, PD, or CR Progressive disease (PD): >=20% increase in the SoL; from smallest SoL. Or appearance of new lesion | One patient in Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab Arm was not evaluable for response due to patient discontinuing after experiencing a hypersensitivity reaction to cetuximab during the first treatment. | Posted | Median | Full Range | months | every 6-9 weeks; from dose of first study drug to event |
|
|
|
| Secondary | Overall Survival | Follow-up for survival to be done at 3 month intervals for 2 years, then 6 month intervals for up to 5 years from study registration | One patient in Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab Arm was not evaluable for response due to patient discontinuing after experiencing a hypersensitivity reaction to cetuximab during the first treatment. | Posted | Median | Full Range | months | From dose of first study drug to last timepoint known to be alive (median follow-up for all patients was 25.9 months) |
|
|
|
| 11 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | Cetuximab, Oxaliplatin, Capecitabine | Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle | 10 | 11 | 0 | 11 | 11 | 11 |
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Infection with neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hemmorhage | Vascular disorders | Systematic Assessment |
|
| DVT | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Edema | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry/cracked skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fissures | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Paronychia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hand-foot syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Weight loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Parasthesias | Nervous system disorders | Systematic Assessment |
|
| Parasthesias/pain | Nervous system disorders | Systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
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| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |