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

Alternate Title

Phase I Randomized, Pilot Study of Low-Dose Suramin and Docetaxel or Gemcitabine in Patients With Stage IIIB or IV Platinum-Refractory Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	OSU-0238 NCI-5889, NCT00066768, 5889

Trial Description

Purpose:

Drugs used in chemotherapy such as docetaxel and gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining suramin with either docetaxel or gemcitabine may reduce resistance to the drugs and kill more tumor cells.

This randomized phase I trial is studying the side effects and best dose of suramin when given together with either docetaxel or gemcitabine in treating patients with stage IIIB or stage IV non-small cell lung cancer that is refractory to platinum chemotherapy (such as cisplatin, carboplatin, or oxaliplatin).

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• At least 4 weeks since chemotherapy
• No more than two previous chemotherapy regimens
• No previous docetaxel or gemcitabine
• 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 to one of two groups.

Patients in group one will receive an infusion of suramin and a 1-hour infusion of docetaxel.

Patients in group two will receive infusions of suramin and gemcitabine once a week for 2 weeks.

Treatment in both groups may be repeated every 3 weeks for as long as benefit is shown. Some patients may cross over to the other group for treatment after three or six courses.

Patients will be evaluated for at least 1 month.

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

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Miguel Villalona-Calero, MD, Principal investigator		Ph: 614-293-9424

Registry Information
Official Title		A Pilot Study of Low Dose Suramin As Modulator Of Docetaxel And Gemcitabine In Patients With Previously Treated Non-Small Cell Lung Cancer (NSCLC)
Trial Start Date		2003-07-31
Registered in ClinicalTrials.gov		NCT00066768
Date Submitted to PDQ		2003-07-01
Information Last Verified		2005-02-25
NCI Grant/Contract Number		P30-CA15068

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