Trial Of Pemetrexed For Patients With Pancreatic Cancer Which Cannot Be Treated With Surgery Or Is Metastatic

Study Overview

Trial of Pemetrexed for Patients With Pancreatic Cancer Which Cannot be Treated With Surgery or is Metastatic

This study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer who progressed after first line chemotherapy with gemcitabine.

N/A

Pancreatic Cancer

DRUG: pemetrexed

8621
H3E-SB-S041

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-06-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2007-06-20
First Submitted that Met QC Criteria 2007-06-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2007-06-22
First Posted (ESTIMATED) 2007-06-22	Results First Posted N/A	Last Verified 2007-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
To evaluate the efficacy.

Secondary Outcome Measures	Measure Description	Time Frame
To assess tumor response.
To assess time to event efficacy variables including time to progressive disease and overall survival.
To characterize the quantitative and qualitative toxicities of pemetrexed in this population of pancreatic cancer patients.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV), as staged by the American Joint Committee on Cancer (AJCC; Protocol Attachment S041.2; Fleming et al. 1997), and not amenable to resection with curative intent.
Prior systemic first line chemotherapy with gemcitabine single agent or a combination regimen including gemcitabine (not more than one prior systemic chemotherapy allowed).
Uni-dimensionally measurable disease according to the RECIST criteria (Therasse et al. 2000), defined as: At least one lesion that can be accurately measured in at least one dimension, with the longest diameter greater than or equal to 2 cm with conventional techniques or greater than or equal to 1.0 cm with spiral CT scans. Ultrasound and X-ray are NOT allowed to measure or follow lesions.

Prior radiation of equal to or greater than 25% of the bone marrow (Cristy and Eckerman 1987)
Prior immunotherapy, biological therapy, and/or hormonal therapy for pancreas cancer.
Prior systemic chemotherapy with 5-FU.
Patient not yet recovered from the acute toxic effects of the treatment prior to study enrollment.
Radiotherapy within the last 4 weeks before study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record