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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.
In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. The study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new blood vessels in the body. It is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. The other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine/carboplatin/bevacizumab | Experimental | A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding. | Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival for Patients Treated With the Regimen. | The period of time from study entry until disease progression or date of last contact. | To progression of Disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry J. Copeland, MD | Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University & James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18829088 | Result | Richardson DL, Backes FJ, Seamon LG, Zanagnolo V, O'Malley DM, Cohn DE, Fowler JM, Copeland LJ. Combination gemcitabine, platinum, and bevacizumab for the treatment of recurrent ovarian cancer. Gynecol Oncol. 2008 Dec;111(3):461-6. doi: 10.1016/j.ygyno.2008.08.011. Epub 2008 Sep 30. |
| Label | URL |
|---|---|
| Jamesline | View source |
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February 2006 through August 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine/Carboplatin/Bevacizumab | A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle. Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle. Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle Carboplatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Gemcitabine | Drug | A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle |
|
| Carboplatin | Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine/Carboplatin/Bevacizumab | A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle. Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle. Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administred on day 1 and day 15 of a 28 day cycle Carboplatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| 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 | patients |
| |||||||||||||||||||||||
| ECOG (Eastern Cooperative Oncology Group) Performance Status | Number | patients |
| |||||||||||||||||||||||
| Primary disease site | Number | patients |
| |||||||||||||||||||||||
| Primary disease stage | Number | patients |
| |||||||||||||||||||||||
| Primary disease grade | Number | patients |
| |||||||||||||||||||||||
| Platinum-free interval | Median | Full Range | months |
| ||||||||||||||||||||||
| Disease status at study enrollment | Number | patients |
|
| 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 | Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding. | Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation. | Posted | Median | 95% Confidence Interval | months | up to 6 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival for Patients Treated With the Regimen. | The period of time from study entry until disease progression or date of last contact. | Posted | Median | 95% Confidence Interval | months | To progression of Disease |
|
|
Toxicity was graded according to the CTCAE-3. Patients were observed for adverse events fro 30 days after treatment discontinuation, and for survival every 3 months until death.
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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/Carboplatin/Bevacizumab | A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle. Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle. Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle Carboplatin | 4 | 45 | 39 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cerebrovascular events | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematologic | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 and 4 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry Copeland, MD | The Ohio State University Comprehensive Cancer Center | 614-293-8697 | Larry.Copeland@osumc.edu |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Tubal |
|
| Stage 4 (cancer has spread to distant organs) |
|
|