Trial Outcomes & Findings for Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer (NCT NCT00702299)
NCT ID: NCT00702299
Last Updated: 2016-01-01
Results Overview
If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the maximum tolerated dose would be determined to be the next lower dose level.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
18 months
Results posted on
2016-01-01
Participant Flow
Participant milestones
| Measure |
Receiving Treatment
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Receiving Treatment
n=15 Participants
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
61.73 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsIf none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the maximum tolerated dose would be determined to be the next lower dose level.
Outcome measures
| Measure |
Receiving Treatment
n=15 Participants
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
Pemetrexed Dose 750 mg/m2
Level 4 Pemetrexed dose 750 mg/m2
|
Pemetrexed Dose 1,000mg/m2
Level 5 Pemetrexed dose 1,000mg/m2
|
|---|---|---|---|
|
Maximum-tolerated Dose of Pemetrexed With a Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)
|
500 mg/m2
|
—
|
—
|
PRIMARY outcome
Timeframe: 18 monthsIf none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the Maximum Tolerance Dose (MTD) would be determined to be the next lower dose level.
Outcome measures
| Measure |
Receiving Treatment
n=15 Participants
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
Pemetrexed Dose 750 mg/m2
Level 4 Pemetrexed dose 750 mg/m2
|
Pemetrexed Dose 1,000mg/m2
Level 5 Pemetrexed dose 1,000mg/m2
|
|---|---|---|---|
|
Patients That Completed at Least 6 Courses of Therapy of Pemetrexed Along With Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)at the Determined Maximum Tolerated Dose
|
80.0 % of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 18 monthsToxicity was assessed by NCI Common Toxicity Criteria for Adverse Effects v3.0
Outcome measures
| Measure |
Receiving Treatment
n=15 Participants
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
Pemetrexed Dose 750 mg/m2
Level 4 Pemetrexed dose 750 mg/m2
|
Pemetrexed Dose 1,000mg/m2
Level 5 Pemetrexed dose 1,000mg/m2
|
|---|---|---|---|
|
Patients Experienced Grade >=3 Toxicity at Dose Level 5 (1,000 mg/m2 IP Pemetrexed)
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsProgression was evaluated with posttreatment CT scans and measured changes in cancer antigen 125 levels 6 months after the initiation of the treatment regimen, or within one month after discontinuation of treatment if stopped early. Cancer antigen 125 response in evaluable patients (N=13) was analyzed using the modified Gynecologic Cancer Intergroup (GCIG) criteria. There was one evaluable patient by Response Evaluation Criteria in Solid Tumors(RECIST) criteria
Outcome measures
| Measure |
Receiving Treatment
n=15 Participants
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
Pemetrexed Dose 750 mg/m2
Level 4 Pemetrexed dose 750 mg/m2
|
Pemetrexed Dose 1,000mg/m2
Level 5 Pemetrexed dose 1,000mg/m2
|
|---|---|---|---|
|
Progression-free Survival at 18 Months as Assessed by Cancer Antigen 125
|
78.6 % of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Average Length of follow-up 788 daysOutcome measures
| Measure |
Receiving Treatment
n=15 Participants
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
Pemetrexed Dose 750 mg/m2
Level 4 Pemetrexed dose 750 mg/m2
|
Pemetrexed Dose 1,000mg/m2
Level 5 Pemetrexed dose 1,000mg/m2
|
|---|---|---|---|
|
Overall Survival
|
680 Days
Interval 16.0 to 1233.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsCmax levels were found through plasma collected between 0.5 to 4 hours and at 24 hours after initiation of intraperitoneal administration
Outcome measures
| Measure |
Receiving Treatment
n=3 Participants
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
Pemetrexed Dose 750 mg/m2
n=3 Participants
Level 4 Pemetrexed dose 750 mg/m2
|
Pemetrexed Dose 1,000mg/m2
n=3 Participants
Level 5 Pemetrexed dose 1,000mg/m2
|
|---|---|---|---|
|
Pharmacokinetics (Mean Cmax, ug/mL)for Different Dosages of Pemetrexed
|
25.1 ug/mL
Standard Deviation 1.3
|
39.3 ug/mL
Standard Deviation 7.3
|
38.7 ug/mL
Standard Deviation 11.2
|
Adverse Events
Receiving Treatment
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Receiving Treatment
n=15 participants at risk
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
|---|---|
|
General disorders
Mortality
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Number of events 2 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
General disorders
Unknown Hospitalization not required
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
Other adverse events
| Measure |
Receiving Treatment
n=15 participants at risk
Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
General disorders
Fatigue
|
20.0%
3/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Skin and subcutaneous tissue disorders
Other-Skin
|
20.0%
3/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Psychiatric disorders
Anoxeria
|
20.0%
3/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Nonmalignant Ascities
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Dysgeusia
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Oral Mucositis
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Rectal Bleeding
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Infections and infestations
Febrile Neutropenia
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Infections and infestations
Infection- abdomen
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Infections and infestations
Opportunistic infection
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Infections and infestations
Tachycardia
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Metabolism and nutrition disorders
Creatinine
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
6.7%
1/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
13.3%
2/15 • 18 months
Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60