Pancreas CancerPhase 2NCT00864513
Study of Pemetrexed for Second-Line Pancreas Cancer
A Phase 2 study testing pemetrexed in people with Pancreas Cancer, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital/Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
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.
Read the 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.
- Conditions
- Pancreas Cancer
- Being tested
- pemetrexed
- Keywords
- pancreas, metastatic, recurrent
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Also called Alimta, LY231514, NSC# 698037
pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Experimental | pemetrexed Receives: Drug: pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after last patient enrolled
Secondary outcomes (3)
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
Measured: Within two months of the completion of the last dose of chemotherapy
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.
Measured: Within two months of the last dose of chemotherapy
Number of Participants With Adverse Events
Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
Measured: 30 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: At interim analysis the study did not meet the response criteria to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Jimmy Hwang, Georgetown University
- Investigators
- Jimmy J Hwang, M.D., Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864513
- Sponsor's protocol ID
- IIT2007022
- Other IDs
- 2007-022
- Status last verified
- Dec 2015
- First submitted
- 17 Mar 2009
- Last updated
- 8 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
- ClinicalTrials.gov ID
- NCT00864513
- Acronym / sponsor ID
- IIT2007022
- Conditions
- Pancreas Cancer
- Keywords
- pancreas, metastatic, recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At interim analysis the study did not meet the response criteria to continue
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Posted 8 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Experimental | Drug: pemetrexedpemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- Any prior treatment with pemetrexed
- More than one prior chemotherapy regimen
- HIV positive on antiretroviral therapy
- Pregnant or lactating
- Prior organ allograft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexedAlso: Alimta, LY231514, NSC# 698037pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles | Drug | chemotherapy |
Primary outcome
Progression-free Survival
Time frame: 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.
3 secondary outcomes
Objective Response
Time frame: Within two months of the completion of the last dose of chemotherapy
CA 19-9 Response
Time frame: Within two months of the last dose of chemotherapy
Number of Participants With Adverse Events
Time frame: 30 days after last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmy J Hwang, M.D. principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed in people with Pancreas Cancer, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 6 months after last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.