A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
STUDY DESIGN This is an open-label, phase II study. This study will utilize a Simon's
optimum two-stage design with early stopping rules. If at least 8 responses (at least 16%)
were observed among the 50 evaluable patients, this agent would be considered worthy of
further testing in this disease. If no more than 2 responses (no more than 10%) were
observed among the initial 21 patients, the study would be terminated early and declared
negative.
TREATMENT PLAN SJG-136 will be administered daily for 3 consecutive days every 3 weeks as a
20-minute intravenous infusion at a dose of 30 mcg/m2/day. Patients will be premedicated
with dexamethasone 8 mg po daily on days -1, 1, 2, and 3 of each cycle. Patients will be
closely monitored for the development of vascular leak syndrome. Patients will measure their
weight daily starting on Day 1 of Cycle 1 and will start aldactone at 50 mg/day orally if
weight increases by more than 2 lbs, or if grade 1 or worse peripheral edema or dyspnea
occurs, or if there is any increase in pre-existing edema. The primary endpoint is overall
response rate (ORR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)
1.1. The nature and degree of toxicity of SJG-136 in this patient population will be
assessed. Other parameters of response, including progression free survival (PFS), overall
survival (OS) and time to progression (TTP) will be assessed. Treatment will be continued
until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Overall Response Rate (ORR)
To estimate the overall response rate (ORR) to SJG-136 at a dose of 30 mcg/m2/day times three every 21 days in patients with persistent or recurrent, platinum-refractory or resistant epithelial ovarian, primary peritoneal, or fallopian tube carcinoma as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Average of 6 months
No
Marta Ann Crispens, M.D.
Principal Investigator
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
MCC-16219
NCT01199796
August 2010
September 2013
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Hartford Hospital Cancer Clinical Research Office | Hartford, Connecticut 06102 |
Virginia Commonwealth University - VCU Massey Cancer Center | Richmond, Virginia 23298-0034 |