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| Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066768 |
Purpose
RATIONALE: 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.
PURPOSE: 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).
| Condition | Intervention | Phase |
|
Lung Cancer |
Drug: docetaxel Drug: gemcitabine hydrochloride Drug: suramin |
Phase I |
| MedlinePlus related topics: | Cancer Lung Cancer |
| Drug Information available for: | Docetaxel Gemcitabine hydrochloride Gemcitabine Suramin Suramin Hexasodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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) |
| Study Start Date: | July 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, pilot, dose-finding study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity. Patients with complete or partial response after the initial 3 courses optionally continue the same therapy for 3 additional courses. Patients with disease progression after 6 courses of treatment on the original arm may cross over and receive treatment on the other arm. Patients with progressive disease or stable disease after the initial 3 courses cross over to the other arm and receive treatment on that arm for 3 additional courses. Patients with responsive or stable disease after the sixth course may continue therapy on that arm.
Cohorts of 6-12 patients in each arm receive doses of suramin calculated from a clinical formula validated in prior clinical trials. Adjustments on the suramin dose are performed if the initial dose is off target and less than 50 µM peak concentration. The optimal dose is defined as the dose at which at least 5 of 6 patients achieve optimal plasma concentrations of suramin and no more than 1 of 6 patients experiences dose-limiting toxicity. In the event of dose-limiting toxicity, doses of docetaxel and gemcitabine are adjusted until the optimal dose in combination with suramin is determined.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: A total of 12-24 patients (6-12 per treatment arm) will be accrued for this study within 6 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
No known brain or leptomeningeal disease, unless all of the following are true:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |||||
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |||||
| Columbus, Ohio, United States, 43210-1240 | |||||
| Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
| National Cancer Institute (NCI) |
| Principal Investigator: | Miguel A. Villalona-Calero, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000318808, OSU-0238, NCI-5889 |
| First Received: | August 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066768 |
| Health Authority: | United States: Federal Government |
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