Pancreas Cancer
Conditions
Keywords
pancreas, metastatic, recurrent
Brief summary
This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine. In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.
Detailed description
This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.
Interventions
DRUGpemetrexed
pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
Sponsors
Eli Lilly and Company
Georgetown University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the pancreas * Prior treatment for distant or locally advanced disease with gemcitabine-based therapy * Measurable or evaluable disease * ECOG performance status 0-2 * Adequate hematological parameters * Adequate baseline liver function * At least 28 days from any major surgery * At least 2 weeks from the last radiation treatment * Must have recovered from reversible toxicities of prior chemotherapy * Must be able to discontinue any nonsteroidal anti-inflammatory medications * Must be willing to receive intramuscular vitamin B12 shots and take oral folate supplements
Exclusion criteria
* Any prior treatment with pemetrexed * More than one prior chemotherapy regimen * HIV positive on antiretroviral therapy * Pregnant or lactating * Prior organ allograft * On concurrent antitumor therapy including radiation therapy or other chemotherapies * Creatinine clearance 45 ml/min or less * Absolute neutrophil count \< 1500 * Platelets \< 75,000 * Bilirubin \> 1.5 times the upper limit of normal * Transaminases \> 3 times the upper limit of normal except in known liver metastasis wherein they may be \</= 5 times upper limit of normal * Clinically significant ascites or pleural effusion that cannot be drained * Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response | 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 |
| CA 19-9 Response | Within two months of the last dose of chemotherapy | 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. |
| Number of Participants With Adverse Events | 30 days after last dose of study drug | Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0 |
Countries
United States
Participant flow
Recruitment details
From 12/2007 to 3/2009 17 patients were enrolled; 2 of which did not receive any treatment.
Participants by arm
| Arm | Count |
|---|---|
| Chemotherapy pemetrexed | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Chemotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 30 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 2 / 15 |
Outcome results
Primary
Progression-free Survival
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.
Time frame: 6 months after last patient enrolled
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemotherapy | Progression-free Survival | 59 days |
Secondary
CA 19-9 Response
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy | CA 19-9 Response | 2 participants |
Secondary
Number of Participants With Adverse Events
Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
Time frame: 30 days after last dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy | Number of Participants With Adverse Events | 2 participants |
Secondary
Objective Response
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
Time frame: Within two months of the completion of the last dose of chemotherapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy | Objective Response | 0 participants |