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| ID | Type | Description | Link |
|---|---|---|---|
| SR05-918 |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer following cytoreductive surgery. Patients with residual large volume disease and/or bowel involvement will be excluded, to minimize the risk of bowel perforation.
All patients must be at least 4 weeks from cytoreductive surgery before starting treatment. Patients will be randomized to receive treatment with either paclitaxel/carboplatin + sorafenib or paclitaxel/carboplatin. Paclitaxel/carboplatin will be repeated every 21 days for a maximum of 6 cycles. Patients with objective response/stable disease after completing 6 courses of chemotherapy will continue sorafenib until disease progression or for a total of 12 months.
- Regimen A:
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1
Carboplatin AUC 6 infused over 20 minutes IV, Day 1
Sorafenib 400mg PO bid
- Regimen B:
Paclitaxel 175mg/m2, 1-3 hour IV infusion, Day 1
Carboplatin AUC 6.0, 20 minute IV infusion, Day 1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel/Carboplatin/Sorafenib | Active Comparator | Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid |
|
| Paclitaxel/carboplatin | Active Comparator | Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug |
|
| |
| Paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Progression-free Survival | The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a > 50% decrease in the serum CA-125 level. |
Not provided
Inclusion Criteria:
Histologically confirmed, stage III or IV epithelial ovarian carcinoma
No previous treatment with chemotherapy or radiation therapy
All patients must have undergone cytoreductive surgery, with the
following results:
No residual tumor nodule > 3cm
No residual tumor involvement of the bowel (ie. invasion into bowel
wall)
No residual intestinal obstruction
Measurable or evaluable disease. Patients with elevated CA-125 levels
and/or evaluable disease per RECIST criteria are eligible.
ECOG performance status 0 or 1.
ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL.
Total bilirubin ≤ 1.5 x upper limits of normal (ULN), ALT and AST ≤ 2.5 x
ULN (≤ 5 x ULN for patients with liver metastases)
Serum creatinine _ 1.5 x ULN
INR < 1.5 or a PT/PTT within normal limits. Patients receiving anticoagulation
treatment with an agent such as warfarin or heparin may be
allowed to participate. For patients on warfarin, the INR may be > 1.5,
and should be measured prior to initiation of sorafenib and monitored at
least weekly until INR is stable in the desired therapeutic range.
Women of childbearing potential must have a negative serum pregnancy
test performed within 7 days prior to start of treatment.
Patients must be able to understand the nature of this study and give
written informed consent.
Exclusion Criteria:
Age < 18 years
Active cardiac disease, including: A) congestive heart failure > class II
NYHA , B) unstable angina or onset of angina within last 3 months, C) myocardial infarction within 6 months
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Patients with CNS metastases. Patients with neurological symptoms
must undergo a CT scan/MRI of the brain to exclude brain metastasis.
Uncontrolled hypertension defined as systolic blood pressure > 150mmHg or diastolic pressure > 90mmHg, despite optimal medical management
Known HIV, chronic hepatitis B or chronic hepatitis C infections
Women who are pregnant or lactating. Women of childbearing potential
must agree to use adequate contraception from time of study entry until
at least 3 months after the last administration of study drug.
Active clinically serious infection (> grade 2)
Thrombotic or embolic events such as cerebral vascular accident
including transient ischemic attacks within the last 6 months.
Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of
starting treatment.
Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of
starting treatment
Serious non-healing wound, ulcer, or bone fracture
Evidence of history of bleeding diathesis or coagulopathy
Major surgery, open biopsy, or significant traumatic injury within 4 weeks
of starting treatment.
Any condition that impairs the ability to swallow whole pills
Patients with any type of malabsorption
Known or suspected allergy to any of the agents used in this treatment
Use of St. John's Wort or rifampin
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| Name | Affiliation | Role |
|---|---|---|
| John D. Hainsworth, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Arkansas Clinic | Jonesboro | Arkansas | 72401 | United States | ||
| Holy Cross Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37185961 | Derived | Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel/Carboplatin/Sorafenib | Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid |
| FG001 | Paclitaxel/Carboplatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 6 Cycles of Study Treatment |
|
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| Drug |
Paclitaxel |
|
| Carboplatin | Drug | Carboplatin |
|
| 18 months |
| Overall Survival (OS) | Overall survival was measured from the date of study entry until the date of death | 18 months |
| Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib | Number of patients experiencing treatment-related adverse events | 18 months |
| Fort Lauderdale |
| Florida |
| 33308 |
| United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States |
| Gulfcoast Oncology Associates | St. Petersburg | Florida | 33705 | United States |
| Medical College of Georgia Cancer Specialists | Augusta | Georgia | 30912 | United States |
| Providence Medical Group | Terre Haute | Indiana | 47802 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| National Capital Clinical Research Consortium | Bethesda | Maryland | 20817 | United States |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29210 | United States |
| Tennessee Valley Clinical Research | Chattanooga | Tennessee | 37411 | United States |
| Family Cancer Center | Collierville | Tennessee | 38017 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | United States |
| Peninsula Cancer Center | Newport News | Virginia | 23601 | United States |
Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
| COMPLETED |
|
| NOT COMPLETED |
|
| Maintenance Sorafenib to Month 12 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel/Carboplatin/Sorafenib | Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid Sorafenib Paclitaxel: Paclitaxel Carboplatin: Carboplatin |
| BG001 | Paclitaxel/Carboplatin | Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV Paclitaxel: Paclitaxel Carboplatin: Carboplatin |
| BG002 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||
| Sex: Female, Male | 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 | 2-year Progression-free Survival | The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 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 | Posted | Number | percentage of participants | 2 years |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a > 50% decrease in the serum CA-125 level. | Posted | Number | participants | 18 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival was measured from the date of study entry until the date of death | Posted | Median | 95% Confidence Interval | months | 18 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib | Number of patients experiencing treatment-related adverse events | Posted | Number | participants | 18 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 | Paclitaxel/Carboplatin/Sorafenib | Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid Sorafenib Paclitaxel: Paclitaxel Carboplatin: Carboplatin | 12 | 43 | 43 | 43 | ||
| EG001 | Paclitaxel/Carboplatin | Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV Paclitaxel: Paclitaxel Carboplatin: Carboplatin | 10 | 42 | 42 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, small bowel obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, disease progression | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, failure to thrive | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Other, pancytopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, electrolyte imbalance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders - Other, nausea/vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, mouth ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, stomatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D. Hainsworth, MD | Sarah Cannon Research Institute | 1-877-691-7274 | asksarah@scresearch.net |
| ID | Term |
|---|---|
| D010051 | Ovarian 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 |
Not provided
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
|
|
|
|