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| ID | Type | Description | Link |
|---|---|---|---|
| IUCRO-0166 | Other Identifier | Indiana Univesity Simon Cancer Center | |
| AVF4003s | Other Identifier | Industry Drug Sponsor |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors.
This study proposes to look at the established combination of oxaliplatin and bevacizumab as used in colorectal cancer in refractory germ cell tumor patients. Oxaliplatin is a drug of known activity. Although bevacizumab has no single agent data, it combines dramatically well with numerous chemotherapy drugs, such as oxaliplatin increasing response rates and improving survival. Furthermore, VEG-F appears to be an important target in germ cell tumors as it does in so many other types of solid tumors. We will be using the identical dosages of oxaliplatin + bevacizumab as has been utilized in previously treated colorectal cancer, without the addition of 5-FU + leucovorin. This dose and schedule has been proven to be safe and effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxaliplatin & bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab and Oxaliplatin | Drug | Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Twelve Month Disease-free Survival Rate | The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug. | 12 month post completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (Complete and Partial Response) | The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug 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. |
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Inclusion Criteria:
Exclusion Criteria:
NOTE THE FOLLOWING GUIDELINES FOR USE IN THIS PROTOCOL:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Einhorn, MD | Indiana Univeristy School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Univeristy Cancer Center | Indianapolis | Indiana | 46202 | United States | ||
| University of Pennsylvania:Abramson Cancer Center |
This protocol was based on getting at least 18 evaluable patients. Since the response data had looked promising, an additional 11 patients were added to obtain more accurate estimates of response.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxaliplatin & Bevacizumab | Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxaliplatin & Bevacizumab | Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes |
| 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 | Twelve Month Disease-free Survival Rate | The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug. | All patients enrolled and received treatment. | Posted | Number | 90% Confidence Interval | percentage of participants | 12 month post completion of treatment |
|
|
beginning of treatment until the end of the study for up to 5 years
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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 | Oxaliplatin & Bevacizumab | Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence H. Einhorn, M.D. | IndianaU | (317) 944-0920 | leinhorn@iu.edu |
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| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| completion of study, up to 5 years |
| Duration of Remission (CR + PR) | Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis. | completion of study, up to 5 years |
| Overall Survival | Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis. | completion of study, up to 5 years |
| Philadelphia |
| Pennsylvania |
| 19104 |
| 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 |
|
| Participants |
|
|
| Secondary | Objective Response Rate (Complete and Partial Response) | The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug 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. | All patients enrolled and received treatment. | Posted | Number | 90% Confidence Interval | percentage of participants | completion of study, up to 5 years |
|
|
|
| Secondary | Duration of Remission (CR + PR) | Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis. | All patients enrolled and received treatment. | Posted | Median | 95% Confidence Interval | months | completion of study, up to 5 years |
|
|
|
| Secondary | Overall Survival | Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis. | All patients enrolled and received treatment. | Posted | Median | 95% Confidence Interval | months | completion of study, up to 5 years |
|
|
|
| 0 |
| 29 |
| 15 |
| 29 |
| HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| TASTE ALTERATION (DYSGEUSIA) | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| INJECTION SITE REACTION/EXTRAVASATION CHANGES | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| PAIN - OTHER | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| INSOMNIA | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| NEUROPATHY: SENSORY | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| MOOD ALTERATION - DEPRESSION | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| PAIN - HEAD/HEADACHE | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| PAIN - ABDOMEN NOS | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| PRURITUS/ITCHING | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |