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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Beth Israel Deaconess Medical Center | OTHER |
| Dana-Farber Cancer Institute | OTHER |
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The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine, Bevacizumab and Erlotinib | Other | single-arm, no masking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Tumor Progression | Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | all patients will be followed for a minimum of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Response rate using RECIST criteria and latest time point available. 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. | after at least one 28-day cycle of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence S. Blaszkowsky, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Beth Israel Deaconess Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine, Bevacizumab and Erlotinib | single-arm, no masking Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
participants who started treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine, Bevacizumab and Erlotinib | single-arm, no masking Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. |
| 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 | Time to Tumor Progression | Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | participants who started treatment | Posted | Median | 95% Confidence Interval | months | all patients will be followed for a minimum of 4 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 | Gemcitabine, Bevacizumab and Erlotinib | single-arm, no masking Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pumonary embolism | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence S. Blaszkowsky, MD | Massachusetts General Hospital | 6172191230 | LBLASZKOWSKY@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069347 | Erlotinib Hydrochloride |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Erlotinib | Drug | Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. |
|
|
| Gemcitabine | Drug | Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. |
|
|
| Toxicity Profile | Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening | during and after first 28-day cycle of treatment |
| Overall Survival | overall survival (OS) = time from study entry until death from any cause | 5 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 | Response Rate | Response rate using RECIST criteria and latest time point available. 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. | participants with response data available | Posted | Count of Participants | Participants | after at least one 28-day cycle of treatment |
|
|
|
| Secondary | Toxicity Profile | Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening | participants who started treatment | Posted | Count of Participants | Participants | during and after first 28-day cycle of treatment |
|
|
|
| Secondary | Overall Survival | overall survival (OS) = time from study entry until death from any cause | participants who started treatment | Posted | Median | 95% Confidence Interval | months | 5 years |
|
|
|
| 11 |
| 30 |
| 30 |
| 30 |
| Death from disease progression | Endocrine disorders |
|
| Death from infection or sepsis | Infections and infestations |
|
| Hyperbilirubinemia | Metabolism and nutrition disorders |
|
| Brain Infarct | Nervous system disorders |
|
| Neutropenia | Immune system disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Leukocytes | Blood and lymphatic system disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Platelets | Blood and lymphatic system disorders |
|
| ALT- SGPT | Metabolism and nutrition disorders |
|
| Hemoglobin | Blood and lymphatic system disorders |
|
| Neutrophils | Blood and lymphatic system disorders |
|
| AST- SGOT | Metabolism and nutrition disorders |
|
| Abdomen - pain | General disorders |
|
| Anorexia | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Hyponatremia | Metabolism and nutrition disorders |
|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders |
|
| Weight loss | General disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Rigors/chills | General disorders |
|
| Lymphopenia | Blood and lymphatic system disorders |
|
| Alkaline phosphatase | Metabolism and nutrition disorders |
|
| Nose- hemorrhage | General disorders |
|
| Fever w/o neutropenia | General disorders |
|
| Bilirubin | Metabolism and nutrition disorders |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders |
|
| Hypoalbuminemia | Metabolism and nutrition disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Insomnia | General disorders |
|
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders |
|
| Skin-other | Skin and subcutaneous tissue disorders |
|
| Dehydration | Gastrointestinal disorders |
|
| Head/headache | General disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Muco/stomatitis by exam- oral cavity | Gastrointestinal disorders |
|
| Dry skin | Skin and subcutaneous tissue disorders |
|
| Extremity-limb- pain | General disorders |
|
| Hyperkalemia | Metabolism and nutrition disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders |
|
| Hypertension | Cardiac disorders |
|
| Proteinuria | Metabolism and nutrition disorders |
|
| Hypocalcemia | Metabolism and nutrition disorders |
|
| Depression | Nervous system disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Edema limb | Blood and lymphatic system disorders |
|
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders |
|
| Bicarbonate | Metabolism and nutrition disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Muscle- pain | General disorders |
|
| GI-other | Gastrointestinal disorders |
|
| Back- pain | General disorders |
|
| Dizziness | Nervous system disorders |
|
| Infection Gr0-2 neut- upper airway | Infections and infestations |
|
| Chest/thoracic pain NOS | General disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Neurologic-other | Nervous system disorders |
|
| Allergic reaction | Immune system disorders |
|
| Anxiety | Nervous system disorders |
|
| Hypoglycemia | Metabolism and nutrition disorders |
|
| Pain-other | General disorders |
|
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders |
|
| Throat/pharynx/larynx- pain | General disorders |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders |
|
| Nonneuropathic generalized weakness | Musculoskeletal and connective tissue disorders |
|
| Ocular-other | Eye disorders |
|
| Pain NOS | General disorders |
|
| Taste disturbance | Gastrointestinal disorders |
|
| Distention/bloating- abdominal | Gastrointestinal disorders |
|
| Arthritis | Musculoskeletal and connective tissue disorders |
|
| Neuropathy-sensory | Nervous system disorders |
|
| Bruising | Skin and subcutaneous tissue disorders |
|
| Burn | Skin and subcutaneous tissue disorders |
|
| Dry mouth | Gastrointestinal disorders |
|
| Flu-like syndrome | General disorders |
|
| Hiccoughs | Respiratory, thoracic and mediastinal disorders |
|
| Hypomagnesemia | Metabolism and nutrition disorders |
|
| Hypophosphatemia | Metabolism and nutrition disorders |
|
| Joint- pain | General disorders |
|
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders |
|
| Rectum- hemorrhage | General disorders |
|
| Rectum- pain | General disorders |
|
| Renal/GU-other | Renal and urinary disorders |
|
| Sweating | General disorders |
|
| Thrombosis/thrombus/embolism | Vascular disorders |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|
|
| Leukocytes |
|
| Rash: acne/acneiform |
|
| Thrombosis/thrombus/embolism |
|
| Anorexia |
|
| AST - SGOT |
|
| Hemoglobin |
|
| Lymphopenia |
|
| Nonneuropathic generalized weakness |
|
| Upper GI-hemorrhage NOS |
|
| Vascular access-Thrombosis/embolism |
|
| Vessel injury - artery - Other NOS |
|
| Weight loss |
|