Not provided
Not provided
Not provided
Not provided
Not provided
THe study was terminated early due to a lack of accural
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Brigham and Women's Hospital | OTHER |
| Eli Lilly and Company | INDUSTRY |
| Sanofi-Synthelabo |
The main purpose of this study is to begin to collect information and try to learn whether or not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with recurrent mullerian carcinoma. We will also collect more information about the safety and side effects of this combination of drugs. Gemcitabine and oxaliplatin are chemotherapy drugs that kill cancer cells. Bevacizumab is a new anti-cancer drug that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Experimental | All patients received oxaliplatin, gemcitabine, and bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Given intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Response Rate | Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria | Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Time participant remains free of progression of her disease. Evaluated by RECIST criteria | Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months |
| Overall Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neil Horowitz, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy Group | Oxaliplatin plus Gemcitabine plus Bevacizumab |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 |
| 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 | Partial Response Rate | Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria | Posted | Number | percentage of patients on study | Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks) |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE v3 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE v3.0 | Non-systematic Assessment |
The trial was closed after enrolling 19 of the 53 projected patient accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil Horowitz, MD | Dana-Farber Cancer Institute | 617-732-8843 | nhorowitz@partners.org |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
| INDUSTRY |
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxaliplatin | Drug | Given intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression. |
|
| Bevacizumab | Drug | Given intravenously over 30-90 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression. |
|
Duration of time participants are alive after enrolling on the study. Assessed by clinical records |
| Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months |
| Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population. | The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported | Toxicities were assessed every cycle and for up to 30 days after being removed from the trial |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Progression Free Survival | Time participant remains free of progression of her disease. Evaluated by RECIST criteria | 19 | Posted | Median | 95% Confidence Interval | weeks | Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months |
|
|
|
| Secondary | Overall Survival | Duration of time participants are alive after enrolling on the study. Assessed by clinical records | All patients enrolled | Posted | Median | 95% Confidence Interval | weeks | Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months |
|
|
|
| Secondary | Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population. | The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported | All patients enrolled | Posted | Number | percentage of participants | Toxicities were assessed every cycle and for up to 30 days after being removed from the trial |
|
|
|
| 1 |
| 19 |
| 19 |
| 19 |
| Fatigue | General disorders | CTCAE (3.0) |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) |
|
| Nausea/Vomiting | Gastrointestinal disorders | CTCAE (3.0) |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) |
|
| Allergic Reaction to Oxaliplatin | Immune system disorders | CTCAE (3.0) |
|
Not provided
Not provided
| 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |