Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	OSU-0238 NCI-5889, NCT00066768, 5889

Objectives

1. 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.
2. Determine, preliminarily, the antitumor activity of these regimens in these patients.
3. Determine whether suramin plasma concentrations in combination with docetaxel or gemcitabine can be predicted by pretreatment dose calculations based on clinical parameters.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed non-small cell lung cancer
  • Stage IIIB* or IV

   [Note: *Must not be amenable to concurrent radiotherapy and chemotherapy (e.g., presence of pleural effusion or low pulmonary reserve)]




• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• 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

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• Prior radiotherapy allowed

Surgery

• Not specified

Other

• At least 2 weeks since prior epidermal growth factor receptor therapy
• Prior suramin allowed
• No concurrent anti-HIV medications for HIV-positive patients

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9.0 g/dL

Hepatic

• 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

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months
• No congestive heart failure requiring therapy
• No unstable angina

Other

• 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

Expected Enrollment

A total of 12-24 patients (6-12 per treatment arm) will be accrued for this study within 6 months.

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.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Miguel Villalona-Calero, MD, Principal investigator		Ph: 614-293-9424

Registry Information
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)
Trial Start Date		2003-07-31
Registered in ClinicalTrials.gov		NCT00066768 1
Date Submitted to PDQ		2003-07-01
Information Last Verified		2005-02-25
NCI Grant/Contract Number		P30-CA15068

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00066768