Study of Pemetrexed for Second-Line Pancreas Cancer

NCT00864513 | Terminated Phase 2 Results DMC

• 2 other identifiers: IIT20070222007-022
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer

Keywords

pancreas; metastatic; recurrent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Objective Response

  Within two months of the completion of the last dose of chemotherapy

• CA 19-9 Response

  Within two months of the last dose of chemotherapy

• Number of Participants With Adverse Events

  30 days after last dose of study drug

Study Arms (1)

chemotherapy

EXPERIMENTAL

pemetrexed

Drug: pemetrexed

Interventions

pemetrexed 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

Also known as: Alimta, LY231514, NSC# 698037

chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Georgetown University Hospital/Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Recurrence

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Limitations and Caveats

study was closed at interim analysis so only 12 subjects were evaluable for response, 15 subjects received treatment and were evaluable for adverse events

Results Point of Contact

• Title: Dr. Jimmy Hwang
• Organization: Georgetown University

jh96@gunet.georgetown.edu

202-444-2198

Study Officials

• Jimmy J Hwang, M.D.

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: October 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 8, 2015
• Results First Posted: December 8, 2015

Record last verified: 2015-12

Locations

US (1)