Study of Pemetrexed for Second-Line Pancreas Cancer

NCT ID: NCT00864513

Last Updated: 2015-12-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-07-31

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.

Conditions

Pancreas Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy

pemetrexed

Group Type: EXPERIMENTAL

pemetrexed

Intervention Type: DRUG

pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Alimta; LY231514; NSC# 698037

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Jimmy Hwang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jimmy J Hwang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University Hospital/Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2007-022

Identifier Type: -

Identifier Source: secondary_id

IIT2007022

Identifier Type: -

Identifier Source: org_study_id