Lung Cancer Clinical Trial
Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed non-small cell lung cancer
Stage IIIB* or IV
Progressive disease after prior platinum-containing regimen (e.g., cisplatin, carboplatin, or oxaliplatin)
No known brain or leptomeningeal disease, unless all of the following are true:
Lesions were previously irradiated
No concurrent corticosteroids
No clinical symptoms
Performance status - ECOG 0-2
At least 12 weeks
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9.0 g/dL
Bilirubin no greater than 1.5 mg/dL
AST/ALT no greater than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2.5 times ULN
Creatinine no greater than 2.0 mg/dL
No myocardial infarction within the past 6 months
No congestive heart failure requiring therapy
No unstable angina
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active serious infectious process
No grade 2 or greater neuropathy
No uncontrolled diabetes mellitus
No psychiatric disorder that would preclude giving informed consent or interfere with study follow-up
See Disease Characteristics
At least 28 days since prior cytotoxic chemotherapy and recovered
No more than 2 prior chemotherapy regimens
No prior docetaxel
No prior gemcitabine
See Disease Characteristics
See Disease Characteristics
Prior radiotherapy allowed
At least 2 weeks since prior epidermal growth factor receptor therapy
Prior suramin allowed
No concurrent anti-HIV medications for HIV-positive patients
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There is 1 Location for this study
Columbus Ohio, 43210, United States
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