Clinical trial NCT00408603: Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
Official title: A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Keywords: second line treatment
platinum resistant
ovary
ovaries
cancer
epithelial
carcinomas
tumor
Lead sponsor: Sunesis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-12-07
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria
timeFrame: 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
Secondary outcomes:
measure: Progression-free Survival (PFS) Using Kaplan-Meier Methods
timeFrame: 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
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Premiere Oncology of Arizona
state: Arizona
city: Newport Beach
country: United States
facility: Gynecologic Oncology Associates
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington, D.C.
country: United States
facility: Medstar Research Institute at Washington Hospital Center
state: District of Columbia
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C. at Luthern General Advanced Care Center
state: Illinois
city: Louisville
country: United States
facility: Louisville Oncology Clinical Research Program
state: Kentucky
city: Baltimore
country: United States
facility: The Harry and Jeanette Weinberg Institute at Franklin Square
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (MSKCC)
state: New York
city: Portland
country: United States
facility: Kaiser Permanente NW Region
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center at Magee-Womens Hospital
state: Pennsylvania
city: Knoxville
country: United States
facility: Hall and Martin, MD's, P.C.
state: Tennessee
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer Agency at Centre for Southern Interior
state: British Columbia
city: Surrey
country: Canada
facility: BC Cancer Agency at Fraser Valley Centre
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer Agency at Vancouver
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer Agency - Vancouver Island Centre
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre Department of Oncology
state: Ontario
Study officials:
affiliation: Sunesis Pharmaceuticals
name: Sunesis Medical Monitor, MD
role: STUDY_DIRECTOR
References: