Trial Outcomes & Findings for Study of Pemetrexed for Second-Line Pancreas Cancer (NCT NCT00864513)

Results Overview

Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

6 months after last patient enrolled

Results posted on

2015-12-08

Participant Flow

From 12/2007 to 3/2009 17 patients were enrolled; 2 of which did not receive any treatment.

Participant milestones

Participant milestones
Measure	Chemotherapy Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Study of Pemetrexed for Second-Line Pancreas Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy n=15 Participants pemetrexed
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 30 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after last patient enrolled

Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.

Outcome measures

Outcome measures
Measure	Chemotherapy n=15 Participants pemetrexed
Progression-free Survival	59 days Interval 26.0 to 241.0

SECONDARY outcome

Timeframe: Within two months of the completion of the last dose of chemotherapy

Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0

Outcome measures

Outcome measures
Measure	Chemotherapy n=12 Participants pemetrexed
Objective Response	0 participants

SECONDARY outcome

Timeframe: Within two months of the last dose of chemotherapy

Population: Only 10 patients had elevated CA 19-9 at the start of therapy, and were therefore analyzable for this endpoint

CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline.

Outcome measures

Outcome measures
Measure	Chemotherapy n=10 Participants pemetrexed
CA 19-9 Response	2 participants

SECONDARY outcome

Timeframe: 30 days after last dose of study drug

Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0

Outcome measures

Outcome measures
Measure	Chemotherapy n=15 Participants pemetrexed
Number of Participants With Adverse Events	2 participants

Adverse Events

Chemotherapy

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy n=15 participants at risk pemetrexed
Blood and lymphatic system disorders neutropenia	13.3% 2/15 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jimmy Hwang

Georgetown University

Phone: 202-444-2198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place