This phase II trial studies how well pemetrexed disodium and carboplatin work in treating patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVES: I. To evaluate the response rate of combination pemetrexed (pemetrexed disodium) (Alimta) and carboplatin (Paraplatin) in recurrent ovarian, primary peritoneal, and fallopian tube carcinoma. SECONDARY OBJECTIVES: I. To evaluate the progression free interval, overall survival, and adverse effects among patients receiving this drug combination. OUTLINE: Patients receive pemetrexed disodium intravenously (IV) over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Columbia University Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Overall Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors and by Rustin's Criteria (RECIST)
The primary endpoint is overall response rate defined by proportion of patients achieving complete response, partial response based on RECIST V1.1 or Rustin's criteria as appropriate. Based on RECIST V1.1 for targeting lesions from CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall response CR + PR. Based on Rustin's criteria, a response to ca125 has occurred if there is at least a 50% reduction in ca125 level from a pretreatment sample. The response must be confirmed and maintained for at least 28 days.
Time frame: 4.5 years
Incidence of Toxicities
Secondary outcome included detailed measurement of adverse events from treatment assessed according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0.
Time frame: 4.5 years
Overall Survival (OS)
Kaplan-Meier method will be used t analyze the time-to-event data including overall survival (OS) and progression-free survival (PFS)
Time frame: First day of treatment on protocol to the date of death, or for living patients the last date of contact, assessed up to 4.5 years
Progression-free Interval
Kaplan-Meier curve will be used to examine all the time-to-event data points in analyzing progression free interval.
Time frame: Time from the first day of treatment to the day that progression is first noted, assessed up to 4.5 years
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