Trial Outcomes & Findings for Pemetrexed and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT01001910)
NCT ID: NCT01001910
Last Updated: 2024-02-28
Results Overview
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.
COMPLETED
PHASE2
22 participants
4.5 years
2024-02-28
Participant Flow
The sample size calculation was based on the primary endpoint of ORR. According to the Simon 2 stage design, the maximum trial size was set at 46 evaluable patients and stopping rules were based on the error probability limits of α=0.05 and β=0.1. If \< 8 responses were observed among the initial 22 patients, the study would be terminated.
Participant milestones
| Measure |
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.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|
|
Overall Study
Did not meet protocol defined eligibility s7.1.1 for primary outcome
|
6
|
Baseline Characteristics
Pemetrexed and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pemetrexed Disodium, Carboplatin)
n=28 Participants
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.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
|
Site of Disease
Ovary
|
23 Participants
n=5 Participants
|
|
Site of Disease
Primary Peritoneal
|
4 Participants
n=5 Participants
|
|
Site of Disease
Fallopian Tube
|
1 Participants
n=5 Participants
|
|
FIGO Stage at Diagnosis
Stages I/II
|
3 Participants
n=5 Participants
|
|
FIGO Stage at Diagnosis
Stages III/IV
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4.5 yearsPopulation: Intent to Treat Patients were included for primary endpoint analysis of ORR if they completed 3 cycles of therapy. Response was categorized as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) by RECIST criteria. All patients had
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.
Outcome measures
| Measure |
Treatment (Pemetrexed Disodium, Carboplatin)
n=22 Participants
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.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|
|
Overall Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors and by Rustin's Criteria (RECIST)
Complete response
|
4 Participants
|
|
Overall Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors and by Rustin's Criteria (RECIST)
Partial response
|
5 Participants
|
|
Overall Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors and by Rustin's Criteria (RECIST)
Stable disease
|
9 Participants
|
|
Overall Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors and by Rustin's Criteria (RECIST)
Progressive disease
|
4 Participants
|
SECONDARY outcome
Timeframe: 4.5 yearsPopulation: The patients that received pemetrexed disodium with carboplatin treatment were evaluated for an grade, grade 3, and grade 4 toxicities for adverse event confirmations.
Secondary outcome included detailed measurement of adverse events from treatment assessed according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0.
Outcome measures
| Measure |
Treatment (Pemetrexed Disodium, Carboplatin)
n=22 Participants
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.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|
|
Incidence of Toxicities
Hematologic AE Any Grade
|
240 Frequency of event
|
|
Incidence of Toxicities
Non-Hematologic AE Any Grade
|
60 Frequency of event
|
SECONDARY outcome
Timeframe: 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 yearsKaplan-Meier method will be used t analyze the time-to-event data including overall survival (OS) and progression-free survival (PFS)
Outcome measures
| Measure |
Treatment (Pemetrexed Disodium, Carboplatin)
n=22 Participants
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.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|
|
Overall Survival (OS)
PFS
|
6.8 months
Interval 5.1 to 8.7
|
|
Overall Survival (OS)
OS
|
50.3 months
Interval 17.1 to 55.1
|
SECONDARY outcome
Timeframe: Time from the first day of treatment to the day that progression is first noted, assessed up to 4.5 yearsKaplan-Meier curve will be used to examine all the time-to-event data points in analyzing progression free interval.
Outcome measures
| Measure |
Treatment (Pemetrexed Disodium, Carboplatin)
n=22 Participants
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.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|
|
Progression-free Interval
|
6.8 months
Interval 5.1 to 8.7
|
Adverse Events
Treatment (Pemetrexed Disodium, Carboplatin)
Serious adverse events
| Measure |
Treatment (Pemetrexed Disodium, Carboplatin)
n=22 participants at risk
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.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Hematologic
|
36.4%
8/22 • Number of events 71 • The median exposure to combination pemetrexed and carboplatin therapy was 18.9 weeks (range: 3-37.9 weeks). The safety population included all patients who received one cycle of chemotherapy and was included in the analysis of safety data.
Adverse events were graded on a scale of 1 to 4, for unfavorable medical occurrences in a participant whether or not considered related to the participant's participation in the research. The types of toxicities evaluated consisted of "hematologic" versus "non-hematologic." Treatment related deaths were recorded separately from all-cause mortality cases. Frequency of adverse events are calculated based on the total number of events divided by the total number of chemotherapy cycles given.
|
|
General disorders
Non-Hematologic
|
13.6%
3/22 • Number of events 15 • The median exposure to combination pemetrexed and carboplatin therapy was 18.9 weeks (range: 3-37.9 weeks). The safety population included all patients who received one cycle of chemotherapy and was included in the analysis of safety data.
Adverse events were graded on a scale of 1 to 4, for unfavorable medical occurrences in a participant whether or not considered related to the participant's participation in the research. The types of toxicities evaluated consisted of "hematologic" versus "non-hematologic." Treatment related deaths were recorded separately from all-cause mortality cases. Frequency of adverse events are calculated based on the total number of events divided by the total number of chemotherapy cycles given.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place