- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864513
Study of Pemetrexed for Second-Line Pancreas Cancer
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Hospital/Lombardi Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: chemotherapy
pemetrexed
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pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 months after last patient enrolled
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response
Time Frame: Within two months of the completion of the last dose of chemotherapy
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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
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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
|
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.
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Within two months of the last dose of chemotherapy
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Number of Participants With Adverse Events
Time Frame: 30 days after last dose of study drug
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Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
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30 days after last dose of study drug
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jimmy J Hwang, M.D., Georgetown University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Pemetrexed
Other Study ID Numbers
- IIT2007022
- 2007-022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreas Cancer
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Washington University School of MedicineCompletedPancreatic Cancer | Pancreas Cancer | Pancreas Neoplasms | Cancer of Pancreas | Cancer of the PancreasUnited States
-
Joseph J. CullenNational Cancer Institute (NCI); National Institutes of Health (NIH); Holden... and other collaboratorsActive, not recruitingAdenocarcinoma | Pancreatic Neoplasms | Pancreas Cancer | Pancreas Neoplasms | Cancer of Pancreas | Cancer of the Pancreas | Neoplasms, PancreaticUnited States
-
Emory UniversityCompletedPancreas Cancer | Pancreas Neoplasms | Cancer of Pancreas | Cancer of the Pancreas | Neoplasms, PancreaticUnited States
-
Washington University School of MedicineNational Cancer Institute (NCI); BioMed Valley Discoveries, IncTerminatedPancreatic Cancer | Pancreas Cancer | Cancer of Pancreas | Cancer of the PancreasUnited States
-
National Cancer Institute (NCI)CompletedPancreatic Neoplasms | Pancreatic Cancer | Pancreas Cancer | Cancer of Pancreas | Cancer of the PancreasUnited States
-
BioXcel Therapeutics IncIQVIA BiotechWithdrawnPancreatic Cancer | Pancreas Cancer | Cancer of Pancreas | Cancer of the Pancreas | Neoplasms, PancreaticUnited States
-
Baylor Research InstituteUnknownPancreas Cancer | Localized Pancreas Cancer | Non-metastatic Pancreas CancerUnited States
-
AmgenTerminatedPancreatic Cancer | Pancreas Cancer | Cancer of Pancreas | Cancer of the Pancreas
-
Washington University School of MedicineTerminatedPancreatic Cancer | Pancreas Cancer | Cancer of Pancreas | Cancer of the PancreasUnited States
-
Newcastle-upon-Tyne Hospitals NHS TrustMedtronicCompletedPancreas Adenocarcinoma | Chronic Pancreatitis | Pancreas Cancer | Pancreas Neoplasm, BenignUnited Kingdom
Clinical Trials on pemetrexed
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Boehringer IngelheimTerminatedCarcinoma, Non-Small-Cell LungJapan
-
Shanghai Shengdi Pharmaceutical Co., LtdNot yet recruitingNon-squamous Non-small Cell Lung CancerChina
-
Rongjie TaoNational Natural Science Foundation of ChinaUnknown
-
Northwestern UniversityNational Cancer Institute (NCI)UnknownLymphoma | Brain and Central Nervous System Tumors | Metastatic CancerUnited States
-
PfizerTerminatedCarcinoma, Non-Small Cell LungUnited States, Germany, Italy
-
Ain Shams UniversityUnknown
-
GlaxoSmithKlineCompletedLung Cancer, Non-Small CellDenmark, United Kingdom
-
Eli Lilly and CompanyCompletedNon-Small Cell Lung Cancer Metastatic | Nonsquamous Non-Small Cell Neoplasm of Lung | Non-Small Cell Lung Cancer Stage IIIBUnited Kingdom, Sweden
-
Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedCarcinoma, Non-small-cell LungNorway
-
University Hospital, AntwerpEli Lilly and Company; Universiteit AntwerpenCompleted