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Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00702299
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : July 19, 2013
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions Drug: cisplatin
Drug: paclitaxel
Drug: pemetrexed disodium
Other: biologic sample preservation procedure
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Receiving Treatment
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Receiving Treatment
Hide Arm/Group Description 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 Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  40.0%
>=65 years
9
  60.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
61.73  (9.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Maximum-tolerated Dose of Pemetrexed With a Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)
Hide Description 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.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Receiving Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: mg/m2
500
2.Primary Outcome
Title 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
Hide Description 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 Tolerance Dose (MTD) would be determined to be the next lower dose level.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Receiving Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: % of participants
80.0
3.Primary Outcome
Title Patients Experienced Grade >=3 Toxicity at Dose Level 5 (1,000 mg/m2 IP Pemetrexed)
Hide Description Toxicity was assessed by NCI Common Toxicity Criteria for Adverse Effects v3.0
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Receiving Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
2
4.Secondary Outcome
Title Progression-free Survival at 18 Months as Assessed by Cancer Antigen 125
Hide Description Progression 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
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Receiving Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: % of participants
78.6
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Average Length of follow-up 788 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Receiving Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: Days
680
(16 to 1233)
6.Secondary Outcome
Title Pharmacokinetics (Mean Cmax, ug/mL)for Different Dosages of Pemetrexed
Hide Description Cmax levels were found through plasma collected between 0.5 to 4 hours and at 24 hours after initiation of intraperitoneal administration
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed Dose 500mg/m2 Pemetrexed Dose 750 mg/m2 Pemetrexed Dose 1,000mg/m2
Hide Arm/Group Description:
Level 3 Pemetrexed dose 500mg/m2
Level 4 Pemetrexed dose 750 mg/m2
Level 5 Pemetrexed dose 1,000mg/m2
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: ug/mL
25.1  (1.3) 39.3  (7.3) 38.7  (11.2)
Time Frame 18 months
Adverse Event Reporting Description Systematic assessment of adverse events were done through patient evaluations at the beginning of each cycle and after treatment
 
Arm/Group Title Receiving Treatment
Hide Arm/Group Description 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)
All-Cause Mortality
Receiving Treatment
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Receiving Treatment
Affected / at Risk (%) # Events
Total   5/15 (33.33%)    
Gastrointestinal disorders   
Diarrhea   2/15 (13.33%)  2
Small Bowel Obstruction   1/15 (6.67%) 
General disorders   
Mortality   1/15 (6.67%) 
Unknown Hospitalization not required   1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory   1/15 (6.67%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Receiving Treatment
Affected / at Risk (%) # Events
Total   13/15 (86.67%)    
Blood and lymphatic system disorders   
Anemia   2/15 (13.33%) 
Leukopenia   2/15 (13.33%) 
Neutropenia   2/15 (13.33%) 
Thrombocytopenia   2/15 (13.33%) 
Gastrointestinal disorders   
Nonmalignant Ascities   1/15 (6.67%) 
Constipation   1/15 (6.67%) 
Dehydration   1/15 (6.67%) 
Diarrhea   2/15 (13.33%) 
Dysgeusia   1/15 (6.67%) 
Nausea   2/15 (13.33%) 
Oral Mucositis   2/15 (13.33%) 
Rectal Bleeding   1/15 (6.67%) 
Vomiting   2/15 (13.33%) 
General disorders   
Fatigue   3/15 (20.00%) 
Infections and infestations   
Febrile Neutropenia   1/15 (6.67%) 
Infection- abdomen   1/15 (6.67%) 
Opportunistic infection   1/15 (6.67%) 
Tachycardia   1/15 (6.67%) 
Metabolism and nutrition disorders   
Creatinine   2/15 (13.33%) 
Hypokalemia   1/15 (6.67%) 
Hypomagnesemia   1/15 (6.67%) 
Musculoskeletal and connective tissue disorders   
Weakness   1/15 (6.67%) 
Psychiatric disorders   
Anoxeria   3/15 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary   2/15 (13.33%) 
Skin and subcutaneous tissue disorders   
Alopecia   1/15 (6.67%) 
Other-Skin   3/15 (20.00%) 
Indicates events were collected by systematic assessment
A limitation of this study is that max treatment dose was not definitively determined, in that the trial did not proceed at accrue patients at a dose level less than 1,000 mg/m2.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Setsuko Chambers
Organization: University of Arizona
Phone: 520/626.0950
EMail: schambers@azcc.arizona.edu
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00702299    
Obsolete Identifiers: NCT00548873
Other Study ID Numbers: 07-0638-04
P30CA023074 ( U.S. NIH Grant/Contract )
UARIZ-07-0638-04 ( Other Identifier: University of Arizona )
UARIZ-SRC-18183 ( Other Identifier: University of Arizona )
LILLY-UARIZ-07-0638-04 ( Other Identifier: University of Arizona )
UARIZ-BIO07074 ( Other Identifier: University of Arizona )
First Submitted: June 19, 2008
First Posted: June 20, 2008
Results First Submitted: October 1, 2012
Results First Posted: July 19, 2013
Last Update Posted: January 1, 2016