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

Alternate Title

Phase I Study of Bortezomib in Combination With Gemcitabine and Carboplatin in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	CCC-PHI-40 CHNMC-PHI-40, NCI-5856, 5856, NCT00052338

Trial Description

Purpose:

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and bortezomib may kill more tumor cells.

Phase I trial to study the effectiveness of combining bortezomib with gemcitabine and carboplatin in treating patients who have advanced or recurrent non-small cell lung cancer.

Eligibility:

• At least 18 years old
• Evaluable disease
• No more than one previous chemotherapy regimen
• At least 4 weeks since chemotherapy or radiation therapy
• No previous gemcitabine or bortezomib
• 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 receive an infusion of bortezomib on days 1, 4, 8, and 11. They will also receive an infusion of gemcitabine on days 1 and 8 and an infusion of carboplatin on day 1. Treatment may be repeated every 3 weeks for up to six courses. Patients will be evaluated periodically.

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

California Cancer Consortium

Angela Davies, MD, Protocol chair		Ph: 916-734-3771

Registry Information
Official Title		A Phase I Study Of PS-341 In Combination With Gemcitabine And Carbloplatin In Selected Stage IIIB Or IV Non-Small Cell Lung Cancer
Trial Start Date		2002-12-06
Registered in ClinicalTrials.gov		NCT00052338
Date Submitted to PDQ		2002-09-27
Information Last Verified		2004-07-16
NCI Grant/Contract Number		CA33572, CM17107

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