Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Study of Pemetrexed Disodium With or Without Sorafenib Tosylate as Second-Line Therapy in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Basic Trial Information

Trial Description

Purpose:

Pemetrexed disodium and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib may kill more tumor cells.

This randomized phase II trial is studying pemetrexed disodium and sorafenib to see how well they work compared with pemetrexed disodium alone as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• Received one previous chemotherapy regimen
• No previous pemetrexed disodium or sorafenib
• At least 2 weeks since radiation therapy, biological therapy, or gene therapy
• At least 4 weeks since surgery, open biopsy, or hormone therapy
• At least 3 weeks since chemotherapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive sorafenib by mouth twice a day. They will also receive an infusion of pemetrexed disodium every three weeks. Treatment may continue for as long as benefit is shown.

Patients in group two will receive an infusion of pemetrexed disodium every three weeks. Treatment may continue for as long as benefit is shown.

Patients will undergo blood and tissue sample collection for laboratory studies.

After finishing treatment, patients will be evaluated periodically for up to 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Alex Adjei, MD, PhD, Protocol chair		Ph: 507-538-0268; 800-685-6825 Email: alex.adjei@roswellpark.org
Grace Dy, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicals@mayo.edu

Registry Information
Official Title		Phase II Randomized Study of Pemetrexed With Sorafenib Versus Pemetrexed Alone as Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer
Trial Start Date		2007-09-07
Trial Completion Date		2008-07-14 (estimated)
Registered in ClinicalTrials.gov		NCT00454194
Date Submitted to PDQ		2007-02-12
Information Last Verified		2010-04-09
NCI Grant/Contract Number		CA25224

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