Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGeribulin mesylate
Given IV
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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: * Platinum-resistant disease (progression-free interval \< 6 months) * Platinum-sensitive disease (progression-free interval ≥ 6 months) * 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 * Stage IA or IB endometrial cancer within the past 5 years allowed provided patient is considered disease free * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer. | up to a total of a year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer | From the time of their first treatment with eribulin mesylate | Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events. |
Countries
United States
Participant flow
Recruitment details
Protocol Open to Accrual 4/17/2006 Primary Completion Date 3/13/2012 Recruitment Location at medical clinic
Participants by arm
| Arm | Count |
|---|---|
| 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 | 37 |
| 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. | 37 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not Treated | 1 | 0 |
Baseline characteristics
| Characteristic | Platinum-Sensitive Cohort | Platinum-Resistant Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 15 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 22 Participants | 48 Participants |
| Age, Continuous | 60 years | 61 years | 60 years |
| Region of Enrollment United States | 37 participants | 37 participants | 74 participants |
| Sex: Female, Male Female | 37 Participants | 37 Participants | 74 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 36 | 19 / 37 |
| serious Total, serious adverse events | 17 / 36 | 16 / 37 |
Outcome results
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.
Time frame: up to a total of a year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Platinum-Resistant Disease | Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer. | Partial Response | 2 participants |
| Platinum-Resistant Disease | Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer. | Stable Disease | 16 participants |
| Platinum-Sensitive Disease | Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer. | Partial Response | 7 participants |
| Platinum-Sensitive Disease | Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer. | Stable Disease | 21 participants |
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.
Time frame: From the time of their first treatment with eribulin mesylate
Population: Data were not collected