Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

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

Summary

Phase II trial to study the effectiveness of combining suramin, paclitaxel, and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Suramin

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed advanced non-small cell lung cancer

• Stage IIIB not amenable to concurrent chemotherapy or radiotherapy (e.g., pleural effusion or low pulmonary reserve)

• Stage IV

• Measurable disease

• Meets criteria for 1 of the following:

• Chemotherapy naive (phases I and II) (phase I closed to accrual 1/29/02) (phase II [chemotherapy-naive patients] closed to accrual 9/1/03)

• Previously treated (phase I) (phase I closed to accrual 1/29/02)

• Received no more than 1 prior chemotherapy regimen

• Chemotherapy refractory, defined as disease progression during or within 3 months after carboplatin/paclitaxel chemotherapy (phase II)

• No known brain or leptomeningeal disease unless previously irradiated, currently not undergoing corticosteroid therapy, and clinically asymptomatic

• Performance status - ECOG 0-2

• At least 12 weeks

• Absolute neutrophil count at least 1,500/mm^3

• Hemoglobin at least 9.0 g/dL

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 mg/dL

• AST and ALT no greater than 2.5 times upper limit of normal

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 50 mL/min

• Calcium less than 11.5 mg/dL

• No history of myocardial infarction within the past 6 months

• No history of congestive heart failure requiring therapy

• No history of unstable angina

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active serious infection

• HIV negative

• No concurrent uncontrolled diabetes mellitus

• No known hypersensitivity to Cremophor EL

• No grade 2 or greater neuropathy

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No known psychiatric condition that would preclude study compliance

• At least 28 days since prior cytotoxic chemotherapy and recovered

• Prior radiotherapy allowed except to indicator lesion