Trial Information

A Pilot Study of Low Dose Suramin as Modulator of Docetaxel and Gemcitabine in Patients With Previously Treated Non-Small Cell Lung Cancer (NSCLC)

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.