Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
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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
Condition | Intervention | Phase |
---|---|---|
Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer |
Drug: eribulin mesylate |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer |
- Objective response rate (CR + PR) to treatment with eribulin mesylate in patients with recurrent ovarian, fallopian tube, or peritoneal cancer [ Time Frame: Baseline and every 6 weeks ] [ Designated as safety issue: No ]Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Reported separately for patients with platinum-resistant disease and potentially platinum-sensitive disease. The 95% confidence intervals should be provided.
- Toxicity profile of eribulin mesylate in patients with recurrent ovarian, fallopian tube, or peritoneal cancer [ Time Frame: From the time of their first treatment with eribulin mesylate ] [ Designated as safety issue: Yes ]Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided.
Estimated Enrollment: | 74 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | January 2100 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Treatment (chemotherapy)
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.
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Drug: eribulin mesylate
Given IV
Other Names:
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts 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
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Martee Hensley | Memorial Sloan-Kettering Cancer Center |
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00334893 History of Changes |
Obsolete Identifiers: | NCT01645592, NCT01664403 |
Other Study ID Numbers: | NCI-2009-00169, 06-027, CDR0000481534, N01CM17105 |
Study First Received: | June 7, 2006 |
Last Updated: | August 24, 2012 |
Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Ovarian Neoplasms Abdominal Neoplasms Neoplasms by Site Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Neoplasms by Histologic Type Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on October 16, 2012