Study of Pemetrexed for Second-Line Pancreas Cancer

• ClinicalTrials.gov Identifier: NCT00864513
• Recruitment Status: Terminated
• First Posted: March 18, 2009
• Results First Posted: December 8, 2015
• Last Update Posted: December 8, 2015
• Sponsor: Georgetown University
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): Jimmy Hwang, Georgetown University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pancreas Cancer	Drug: pemetrexed	Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
• Study Start Date: October 2007
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: July 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: chemotherapy; pemetrexed	Drug: pemetrexed; 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: Alimta; LY231514; NSC# 698037

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Objective Response [ Time Frame: 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
2. 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.
3. Number of Participants With Adverse Events [ Time Frame: 30 days after last dose of study drug ]
   Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, District of Columbia

Georgetown University Hospital/Lombardi Cancer Center

Washington, District of Columbia, United States, 20007

Sponsors and Collaborators

Georgetown University

Eli Lilly and Company

Investigators

• Principal Investigator: Jimmy J Hwang, M.D.; Georgetown University

More Information

• Responsible Party: Jimmy Hwang, Principal Investigator, Georgetown University
• ClinicalTrials.gov Identifier: NCT00864513
• Other Study ID Numbers: IIT2007022; 2007-022
• First Posted: March 18, 2009
• Results First Posted: December 8, 2015
• Last Update Posted: December 8, 2015
• Last Verified: December 2015

Keywords provided by Jimmy Hwang, Georgetown University:

pancreas; metastatic; recurrent

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors