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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Novartis | INDUSTRY |
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This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.
Upon determination of eligibility, patients will be receive:
Bevacizumab + Erlotinib + Imatinib
A brief phase I dose escalation study will be performed to define the imatinib dose that will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 10mg/kg IV infusion every 2 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | 18 months |
| Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | 18 months | |
| Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | 24 months |
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Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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| Name | Affiliation | Role |
|---|---|---|
| John D. Hainsworth, MD | SCRI Development Innovations, LLC | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18272024 | Result | Hainsworth JD, Spigel DR, Sosman JA, Burris HA 3rd, Farley C, Cucullu H, Yost K, Hart LL, Sylvester L, Waterhouse DM, Greco FA. Treatment of advanced renal cell carcinoma with the combination bevacizumab/erlotinib/imatinib: a phase I/II trial. Clin Genitourin Cancer. 2007 Dec;5(7):427-32. doi: 10.3816/CGC.2007.n.030. |
| Label | URL |
|---|---|
| Published article in Clinical Genitourinary Cancer | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab/Erlotinib/Imatinib | In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab/Erlotinib/Imatinib | In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily |
| 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), the Percentage of Patients Who Experience an Objective Benefit From Treatment | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Eighty-seven of 94 patients (93%) received ≥ 2 months of treatment and were fully evaluable for response. Seven patients discontinued treatment during the first 8 weeks. One of these 7 patients had evidence of rapid tumor progression, whereas the remaining 6 patients discontinued treatment because of toxicity or for personal reasons. | Posted | Number | 95% Confidence Interval | percentage of participants | 18 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 | Bevacizumab/Erlotinib/Imatinib | In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive Emergency | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Hainsworth, MD | Sarah Cannon Research Institute | 1-877-691-7274 | asksarah@scresearch.net |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069347 | Erlotinib Hydrochloride |
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Erlotinib | Drug | 150 mg po daily |
|
|
| Imatinib | Drug | 400-600mg daily |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | All patients enrolled in the trial | Posted | Median | 95% Confidence Interval | months | 18 months |
|
|
|
| Primary | Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | All patients enrolled in the study | Posted | Median | 95% Confidence Interval | months | 24 months |
|
|
|
| 45 |
| 94 |
| 83 |
| 94 |
| Pulmonary Embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute Sepsis Syndrome | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Large Pericetal Abscess | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Severe Enteritis with likely bowel perforation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Spinal Cord compression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Impending pathologic fracture of Right Proximal femur | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Superficial subcutaneous postoperative wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Progressive Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Hip Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Wedge resection/biopsy of known nodule at left | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
|
| Choleocystitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Rt. pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Subacute Infarct left posterior cerebral artery | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| GU obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute Renal Insufficiency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| CHF | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Wound Complication | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac Ischemia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fecal Impaction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Intercranial Hemorrhage | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoptysis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gross Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Duodenal Ulcer with Bleeding | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hair Loss/Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Arthralgia |
|
| Rigor/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cramps (abdominal) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood Alteration - Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bleeding | Vascular 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 |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperbilirubinemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (abdominal) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (back) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sinus drainage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin (dry) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin (pruritis) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste change | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste disturbance | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight Loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011743 | Pyrimidines |