Clinical trial NCT00864513: Study of Pemetrexed for Second-Line Pancreas Cancer
Official title: A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreas Cancer
Keywords: pancreas
metastatic
recurrent
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2009-03-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: 6 months after last patient enrolled
Secondary outcomes:
measure: Objective Response
timeFrame: Within two months of the completion of the last dose of chemotherapy
measure: CA 19-9 Response
timeFrame: Within two months of the last dose of chemotherapy
measure: Number of Participants With Adverse Events
timeFrame: 30 days after last dose of study drug
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital/Lombardi Cancer Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Jimmy J Hwang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: