Study of Pemetrexed for Second-Line Pancreas Cancer

• Sponsor: Georgetown University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00864513
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 17
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Drug: pemetrexed	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: chemotherapy pemetrexed	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; Other Names: Alimta LY231514 NSC# 698037

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival [6 months after last patient enrolled]

   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.

Secondary Outcome Measures

1. Objective Response [Within two months of the completion of the last dose of chemotherapy]

   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

2. CA 19-9 Response [Within two months of the last dose of chemotherapy]

   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.

3. Number of Participants With Adverse Events [30 days after last dose of study drug]

   Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown University Hospital/Lombardi Cancer Center	Washington	District of Columbia	United States	20007

Sponsors and Collaborators

• Georgetown University
• Eli Lilly and Company

Investigators

• Principal Investigator: Jimmy J Hwang, M.D., Georgetown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jimmy Hwang, Principal Investigator, Georgetown University
• ClinicalTrials.gov Identifier: NCT00864513
• Other Study ID Numbers: IIT2007022; 2007-022
• First Posted: Mar 18, 2009
• Last Update Posted: Dec 8, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Jimmy Hwang, Principal Investigator, Georgetown University: pancreas; metastatic; recurrent
• Additional relevant MeSH terms: Pancreatic Neoplasms; Pemetrexed

Study Results

Participant Flow

Recruitment Details	From 12/2007 to 3/2009 17 patients were enrolled; 2 of which did not receive any treatment.

Arm/Group Title	Chemotherapy
Arm/Group Description	Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment
Period Title: Overall Study
STARTED	15
COMPLETED	12
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Chemotherapy
Arm/Group Description	pemetrexed
Overall Participants	15
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	11 73.3%
>=65 years	4 26.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (30)
Sex: Female, Male (Count of Participants)
Female	4 26.7%
Male	11 73.3%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival
Description	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.
Time Frame	6 months after last patient enrolled

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemotherapy
Arm/Group Description	pemetrexed
Measure Participants	15
Median (Full Range) [days]	59

2. Secondary Outcome

Title	Objective Response
Description	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
Time Frame	Within two months of the completion of the last dose of chemotherapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemotherapy
Arm/Group Description	pemetrexed
Measure Participants	12
Number [participants]	0 0%

3. Secondary Outcome

Title	CA 19-9 Response
Description	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.
Time Frame	Within two months of the last dose of chemotherapy

Outcome Measure Data

Analysis Population Description

Only 10 patients had elevated CA 19-9 at the start of therapy, and were therefore analyzable for this endpoint

Arm/Group Title	Chemotherapy
Arm/Group Description	pemetrexed
Measure Participants	10
Number [participants]	2 13.3%

4. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
Time Frame	30 days after last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemotherapy
Arm/Group Description	pemetrexed
Measure Participants	15
Number [participants]	2 13.3%

Adverse Events

Arm/Group Title	Chemotherapy
Arm/Group Description	pemetrexed
All Cause Mortality
	Chemotherapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Chemotherapy
	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)
Blood and lymphatic system disorders
neutropenia	2/15 (13.3%)	2
Other (Not Including Serious) Adverse Events
	Chemotherapy
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.