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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Docetaxel; Gemcitabine; Suramin

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