| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00169 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MSKCC-06027 | |||
| NCI-7431 | |||
| CDR0000481534 | |||
| 06-027 | Other Identifier | Memorial Sloan-Kettering Cancer Center | |
| 7431 | Other Identifier | CTEP | |
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| N01CM62206 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well eribulin mesylate works in treating patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVES:
I. Determine the frequency of objective response (complete and partial responses) in patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with E7389 (eribulin mesylate).
SECONDARY OBJECTIVES:
II. Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior platinum sensitivity (yes vs no).
Patients receive eribulin mesylate intravenously (IV) over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemotherapy) | Experimental | Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eribulin mesylate | Drug | Given IV |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer. | 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. | up to a total of a year |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer | Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events. | From the time of their first treatment with eribulin mesylate |
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Inclusion Criteria:
Histologically or cytologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
Recurrent disease after ≥ 1 prior therapy, meeting 1 of the following criteria:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mmby conventional techniques OR ≥ 10 mm by spiral CT scan
No known brain metastasis
Life expectancy > 2 months
ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
WBC ≥ 3,000/mm^3
Bilirubin normal
AST and ALT ≤ 2.5 times upper limit of normal
Creatine normal OR creatinine clearance ≥ 60 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
No history of allergic reaction attributed to compounds of similar chemical or biological composition to E7389
No HIV positivity
No ongoing or active infection
No cardiac arrhythmia
No unstable angina pectoris
No symptomatic congestive heart failure
No psychiatric illness or social situations that would preclude study compliance
No other uncontrolled intercurrent illness
See Disease Characteristics
Recovered from effects of recent surgery, radiotherapy, or chemotherapy
No more than 2 prior cytotoxic therapies with no more than 1 non platinum, non taxane regimen
No prior E7389
More than 14 days since prior hormonal therapy
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
More than 4 weeks since prior radiotherapy
No concurrent antitumor hormonal therapy
No other concurrent investigational agents
No other concurrent anticancer agents or therapies
No granulocyte colony-stimulating factors during the first course of study therapy
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| Name | Affiliation | Role |
|---|---|---|
| Martee Hensley | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Memorial Sloan-Kettering Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21935916 | Derived | Hensley ML, Kravetz S, Jia X, Iasonos A, Tew W, Pereira L, Sabbatini P, Whalen C, Aghajanian CA, Zarwan C, Berlin S. Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: a 2-cohort, phase 2 study. Cancer. 2012 May 1;118(9):2403-10. doi: 10.1002/cncr.26569. Epub 2011 Sep 20. |
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Protocol Open to Accrual 4/17/2006 Primary Completion Date 3/13/2012 Recruitment Location at medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Platinum Resistant Cohort | Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. eribulin mesylate : Given IV |
| FG001 | Platinum Sensitive Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| New York |
| New York |
| 10065 |
| United States |
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. eribulin mesylate : Given IV |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Platinum-Resistant Cohort | Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. eribulin mesylate : Given IV |
| BG001 | Platinum-Sensitive Cohort | Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer. | 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. | Posted | Number | participants | up to a total of a year |
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| Secondary | Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer | Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events. | Data were not collected | Posted | From the time of their first treatment with eribulin mesylate |
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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 | Platinum-Resistant Disease | Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. eribulin mesylate : Given IV | 17 | 36 | 16 | 36 | ||
| EG001 | Platinum-Sensitive Disease | Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. eribulin mesylate : Given IV | 16 | 37 | 19 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death NOS | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death-Disease progression | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin decrease | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocyte count decrease/white blood cell decrease | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophil count decrease | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction-GI-Colon | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain-Cardiac | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain-Chest wall | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Neurological disorder | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Perforation, GI-Small Bowel NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v 3.0 | Systematic Assessment |
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| Lymphocyte count decrease | Investigations | CTCAE v 3.0 | Systematic Assessment |
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| Neutrophil count decrease | Investigations | CTCAE v 3.0 | Systematic Assessment |
| |
| White blood cell decrease | Investigations | CTCAE v 3.0 | Systematic Assessment |
| |
| AST/SGOT increase | Investigations | CTCAE v 3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martee L. Hensley | Memorial Sloan-Kettering Cancer Center | 646-888-4222 | hensleym@mskcc.org |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C490954 | eribulin |
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| >=65 years |
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| Male |
|