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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreas Cancer

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Trial Information

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


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.


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
- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months after last patient enrolled

Safety Issue:

No

Principal Investigator

Jimmy J Hwang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University

Authority:

United States: Institutional Review Board

Study ID:

IIT2007022

NCT ID:

NCT00864513

Start Date:

October 2007

Completion Date:

July 2009

Related Keywords:

  • Pancreas Cancer
  • pancreas
  • metastatic
  • recurrent
  • Pancreatic Neoplasms

Name

Location

Georgetown University Hospital/Lombardi Cancer CenterWashington, District of Columbia  20007