Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00529100

Purpose

Measure the 1 year survival of non small cell lung cancer patients who are being treated with pemetrexed in combination with cisplatin and radiation.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: pemetrexed Drug: cisplatin Procedure: Radiation Therapy	Phase I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Phase 1: determine maximum tolerated dose [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Phase 2: overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Phase 1: pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Phase 2: overall survival [ Time Frame: baseline to date of death from any cause, measure at 2 and 3 years ] [ Designated as safety issue: Yes ]
Phase 2: time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Phase 2: progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Phase 2: tumor response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Determine site of first failure in patients who develop progressive disease [ Time Frame: every cycle ] [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental This is a single arm study with patients receiving pemetrexed, cisplatin and radiation therapy.	Drug: pemetrexed Phase 1: 300 mg/m2, IV, day 1 and day 22 (dose escalation) then 500 mg/m2, IV, q 21 days x 2 cycles Phase 2: cycle 1 dose determined by phase 1 outcome then 500 mg/m2, IV, q 21 days x 2 cycles Drug: cisplatin Phase 1: 25 mg/m2, IV, days 1-3 and 22-24 then 75 mg/m2, IV, q 21 days x 2 cycles Phase 2: 25 mg/m2, IV, days 1-3 and days 22-24 then 75 mg/m2, IV, q 21 days x 2 cycles Procedure: Radiation Therapy Phase 1 and phase 2: 61-65 Gy in 33-35 fractions

Arms

Assigned Interventions

A: Experimental

This is a single arm study with patients receiving pemetrexed, cisplatin and radiation therapy.

Drug: pemetrexed

Phase 1: 300 mg/m2, IV, day 1 and day 22 (dose escalation) then 500 mg/m2, IV, q 21 days x 2 cycles

Phase 2: cycle 1 dose determined by phase 1 outcome then 500 mg/m2, IV, q 21 days x 2 cycles

Drug: cisplatin

Phase 1: 25 mg/m2, IV, days 1-3 and 22-24 then 75 mg/m2, IV, q 21 days x 2 cycles

Phase 2: 25 mg/m2, IV, days 1-3 and days 22-24 then 75 mg/m2, IV, q 21 days x 2 cycles

Procedure: Radiation Therapy

Phase 1 and phase 2: 61-65 Gy in 33-35 fractions

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Some of the requirements to be in this study are:

Patient must be at least 18 years old.
Patient must have been diagnosed with non-small cell lung cancer.
Patient must be able to visit the doctor's office once a week.
Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.

Exclusion Criteria:

Patients cannot participate in this study for any of the following reasons:

Patient has previously had chemotherapy.
Patient has previously had thoracic radiation therapy.
Patient has received treatment within the last 30 days with a drug that has not received approval by Health Canada for any indication at the time of study entry.
Female patient is pregnant or breast-feeding.
Patient is unsuitable to participate in the study in the opinion of the investigator.
Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529100

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Locations

Canada, Alberta
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Eli Lilly
Canada, Ontario
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Eli Lilly

Sponsors and Collaborators

Eli Lilly and Company

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

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10259, H3E-CA-JMHU
Study First Received:	September 12, 2007
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00529100
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009