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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01832 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2009-0186 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well first-line treatment of bevacizumab, carboplatin, and paclitaxel work in treating participants with stage III- IV ovarian, primary peritoneal and fallopian tube cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bevacizumab, carboplatin, and paclitaxel as first-line treatment may work better at treating ovarian, primary peritoneal, and fallopian tube cancer.
PRIMARY OBJECTIVES:
I. To determine whether patients with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers when treated with bevacizumab, carboplatin, and weekly paclitaxel can tolerate at least 4 cycles of therapy regardless of delay or dose modification.
SECONDARY OBJECTIVES:
I. To estimate the efficacy of bevacizumab combined with carboplatin and weekly paclitaxel in patients with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers, as measured by progression-free survival.
II. To evaluate the response rate in patients with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers when treated with bevacizumab, carboplatin, and weekly paclitaxel.
TRANSLATIONAL RESEARCH OBJECTIVES:
I. To assess the predictive value of a set of angiogenic genes whose expression correlates with progression-free survival of patients with epithelial ovarian, peritoneal primary or fallopian tube cancer treated with bevacizumab, carboplatin, and weekly paclitaxel.
II. To assess the relationship among cytokines/chemokines, angiogenesis factors, novel targets of interest and clinical outcome including tumor response and progression-free survival in patients treated with bevacizumab, carboplatin, and weekly paclitaxel.
OUTLINE:
Participants receive paclitaxel intravenously (IV) over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 3 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (paclitaxel, carboplatin, bevacizumab) | Experimental | Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Success | Participants with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers treated with bevacizumab, carboplatin, and weekly paclitaxel that can tolerate at least 4 cycles of therapy regardless of delay or dose modification. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival of Optimal (RO) </= 1cm (PFS) vs Suboptimal > 1 cm | Progression-Free Survival is the period from study entry until disease progression, death or date of last contact. Disease progression defined by imaging or palpation of at least a 20% increase in the sum of the LD of target lesions, the appearance of one or more new lesions, or unequivocal progression of existing nontarget lesions, the date of progression will be defined as the date such lesions were first found to be progressed by imaging or palpation. Estimated the PFS with the Kaplan-Meier product-limit estimator stratified by debulking status (optimal, sub-optimal).The Cox proportional hazards regression model to assess the association of gene expression and cytokines with PFS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Sood | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| MD Anderson Regional Care Center-Katy |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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Recruitment Period: April 2010 to December 2013. All the recruitment was done in medical clinic setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Paclitaxel, Carboplatin, Bevacizumab) | Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2016 |
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| Carboplatin | Drug | Given IV |
|
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| Paclitaxel | Drug | Given IV |
|
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| 2 years |
| Houston |
| Texas |
| 77094 |
| United States |
| MD Anderson Regional Care Center-Bay Area | Nassau Bay | Texas | 77058 | United States |
| MD Anderson Regional Care Center-Sugar Land | Sugar Land | Texas | 77478 | United States |
| MD Anderson Regional Care Center-The Woodlands | The Woodlands | Texas | 77384 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Paclitaxel, Carboplatin, Bevacizumab) | Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | 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 |
|
| 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 | Number of Participants With Treatment Success | Participants with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers treated with bevacizumab, carboplatin, and weekly paclitaxel that can tolerate at least 4 cycles of therapy regardless of delay or dose modification. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival of Optimal (RO) </= 1cm (PFS) vs Suboptimal > 1 cm | Progression-Free Survival is the period from study entry until disease progression, death or date of last contact. Disease progression defined by imaging or palpation of at least a 20% increase in the sum of the LD of target lesions, the appearance of one or more new lesions, or unequivocal progression of existing nontarget lesions, the date of progression will be defined as the date such lesions were first found to be progressed by imaging or palpation. Estimated the PFS with the Kaplan-Meier product-limit estimator stratified by debulking status (optimal, sub-optimal).The Cox proportional hazards regression model to assess the association of gene expression and cytokines with PFS. | 3 participants were not evaluable due to post surgical complications. | Posted | Median | Full Range | Number of months | 2 years |
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Adverse events were assessed from the start of the study until 30 days after the last dose of study medication taken, up to a maximum of 32.8 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 | Treatment (Paclitaxel, Carboplatin, Bevacizumab) | Participants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | 0 | 33 | 3 | 33 | 23 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound dehisence | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Neutropenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutropenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Decrease Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Liver Enzymes | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nail disorder | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anil K. Sood, MD/Professor, Gyn Onc & Reproductive Med | UT MD Anderson Cancer Center | (713) 745-5266 | asood@mdanderson.org |
| Dec 7, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D001948 | Brenner Tumor |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018225 | Neoplasms, Fibroepithelial |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D007074 | Immunoglobulin G |
| D004220 | Disulfides |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| 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 |
| D007132 | Immunoglobulin Isotypes |
| D013440 | Sulfides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006862 | Hydrogen Sulfide |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D056831 | Coordination Complexes |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
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