Study of Pemetrexed for Second-Line Pancreas Cancer

Pancreas Cancer Clinical Trial

Official title:

A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00864513
• Other study ID #: IIT2007022
• Secondary ID: 2007-022
• Status: Terminated
• Phase: Phase 2
• First received: March 17, 2009
• Last updated: December 7, 2015
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: December 2015
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Georgetown University Hospital/Lombardi Cancer Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months after last patient enrolled	No
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	Within two months of the completion of the last dose of chemotherapy	No
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.	Within two months of the last dose of chemotherapy	No
Secondary	Number of Participants With Adverse Events	Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0	30 days after last dose of study drug	Yes