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


Phase 1
18 Years
N/A
Not Enrolling
Both
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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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 ┬ÁM 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of suramin, graded according to the revised NCI CTC version 2.0

Outcome Time Frame:

Up to 30 days after completion of study treatment

Safety Issue:

Yes

Principal Investigator

Miguel Villalona-Calero

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01440

NCT ID:

NCT00066768

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Ohio State University Medical Center Columbus, Ohio  43210