Pemetrexed and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT01001910|
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : October 20, 2021
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Drug: Carboplatin Other: Laboratory Biomarker Analysis Drug: Pemetrexed Disodium||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||February 2015|
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: Laboratory Biomarker Analysis
Drug: Pemetrexed Disodium
- Overall Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors and by Rustin's Criteria (RECIST) [ Time Frame: 4.5 years ]
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.
- Incidence of Toxicities [ Time Frame: 4.5 years ]Secondary outcome included detailed measurement of adverse events from treatment assessed according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0.
- Overall Survival (OS) [ 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 ]Kaplan-Meier method will be used t analyze the time-to-event data including overall survival (OS) and progression-free survival (PFS)
- 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 ]Kaplan-Meier curve will be used to examine all the time-to-event data points in analyzing progression free interval.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|