Pemetrexed Disodium and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Other: Laboratory Biomarker Analysis
Drug: Pemetrexed Disodium
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma|
- Overall objective response rate (RR) based on Response Evaluation Criteria in Solid Tumors and by Rustin Criteria (RECIST) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]An exact 95% confidence interval for the tumor RR will be calculated based on the binomial distribution.
- Incidence of toxicities assessed according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0. [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]Each of the grade 3 or 4 hematologic and non-hematologic toxicities will be determined and divided by the total number of patients to calculate the frequency for each toxicity over the study population. The number of adverse events will also be divided by the number of chemotherapy cycles to determine the frequency per treatment course.
- Overall survival [ 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 8 years ] [ Designated as safety issue: No ]Kaplan-Meier method will be used to analyze the time-to-event data including overall survival.
- Progression-free interval [ Time Frame: Time from the first day of treatment to the day that progression is first noted, assessed up to 8 years ] [ Designated as safety issue: No ]Kaplan-Meier method will be used to analyze the time-to-event data including progression free interval.
|Study Start Date:||July 2008|
|Study Completion Date:||February 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (pemetrexed disodium, carboplatin)
Patients receive pemetrexed disodium 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.
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Pemetrexed Disodium
I. To evaluate the response rate of combination pemetrexed (pemetrexed disodium) (Alimta) and carboplatin (Paraplatin) in recurrent ovarian, primary peritoneal, and fallopian tube carcinoma.
I. To evaluate the progression free interval, overall survival, and adverse effects among patients receiving this drug combination.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001910
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Dennis Kuo||Albert Einstein College of Medicine of Yeshiva University|