Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
- Registration Number
- NCT00408603
- Lead Sponsor
- Sunesis Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.
- Detailed Description
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 183
- Histologically or cytologically documented epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
- Completed at least one Platinum Based Therapy (PBT) regimen (carboplatin, cisplatin, or another organoplatinum compound).
- Evidence of platinum-resistant disease, relapse/progression within 6 months of the completion of PBT, or intolerant to PBT (inability to receive PBT due to hypersensitivity reactions to platinum)
- Patients with primary platinum-resistant disease are allowed to receive no more than one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the management of recurrent or persistent disease after the development of primary platinum-resistance.
- Measurable disease per GOG-RECIST criteria
- GOG Performance Status of 0 or 1
- Radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3 weeks (nitrosurea or mitomycin C within 6 weeks) prior to the anticipated first day of treatment.
- Monoclonal antibody therapy within 4 weeks prior to clinical study entry
- Unresolved or impending bowel obstruction
- Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia
- Prior radiotherapy to more than 25% of the marrow space
- Requiring hemodialysis or peritoneal dialysis
- Myocardial infarction or cerebrovascular accident/transient ischemic attack within the 6 months prior to the anticipated first day of treatment
- Thromboembolic event (deep vein thrombosis [DVT] or pulmonary embolus [PE]) within 28 days prior to the anticipated first day of treatment
- History of active CNS metastases
- Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety or compliance with clinical study procedures.
Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if you meet all study criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All study patients Voreloxin Injection All patients will receive voreloxin injection
- Primary Outcome Measures
Name Time Method Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is \>= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) Using Kaplan-Meier Methods From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression.
For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules.
For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules.
For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment.
Trial Locations
- Locations (20)
Sharp Clinical Oncology Research
🇺🇸San Diego, California, United States
The Harry and Jeanette Weinberg Institute at Franklin Square
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
BC Cancer Agency - Vancouver Island Centre
🇨🇦Victoria, British Columbia, Canada
Kaiser Permanente NW Region
🇺🇸Portland, Oregon, United States
Juravinski Cancer Centre Department of Oncology
🇨🇦Hamilton, Ontario, Canada
BC Cancer Agency at Fraser Valley Centre
🇨🇦Surrey, British Columbia, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
BC Cancer Agency at Vancouver
🇨🇦Vancouver, British Columbia, Canada
Gynecologic Oncology Associates
🇺🇸Newport Beach, California, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Premiere Oncology of Arizona
🇺🇸Scottsdale, Arizona, United States
Medstar Research Institute at Washington Hospital Center
🇺🇸Washington, D.C., District of Columbia, United States
University of Pittsburgh Medical Center at Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
BC Cancer Agency at Centre for Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Oncology Specialists, S.C. at Luthern General Advanced Care Center
🇺🇸Park Ridge, Illinois, United States
Stanford University
🇺🇸Stanford, California, United States
Louisville Oncology Clinical Research Program
🇺🇸Louisville, Kentucky, United States
Memorial Sloan Kettering Cancer Center (MSKCC)
🇺🇸New York, New York, United States
Hall and Martin, MD's, P.C.
🇺🇸Knoxville, Tennessee, United States