Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT00066768
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2003-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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). 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.
Detailed Description:
OBJECTIVES:
I. Determine the safety of low-dose suramin administered with docetaxel or gemcitabine in patients with stage IIIB or IV platinum-refractory non-small cell lung cancer.
II. Determine, preliminarily, the antitumor activity of these regimens in these patients.
III. Determine whether suramin plasma concentrations in combination with docetaxel or gemcitabine can be predicted by pretreatment dose calculations based on clinical parameters.
OUTLINE: This is a randomized, pilot, dose-finding study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive low-dose suramin IV over 30 minutes and docetaxel IV over 1 hour on day 1.
ARM II: Patients receive low-dose suramin IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8.
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.
I. Determine the safety of low-dose suramin administered with docetaxel or gemcitabine in patients with stage IIIB or IV platinum-refractory non-small cell lung cancer.
II. Determine, preliminarily, the antitumor activity of these regimens in these patients.
III. Determine whether suramin plasma concentrations in combination with docetaxel or gemcitabine can be predicted by pretreatment dose calculations based on clinical parameters.
OUTLINE: This is a randomized, pilot, dose-finding study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive low-dose suramin IV over 30 minutes and docetaxel IV over 1 hour on day 1.
ARM II: Patients receive low-dose suramin IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: