Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

In brief

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. Radiation therapy uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of non-small cell lung cancer cells. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without AE-941 for non-small cell lung cancer. This randomized phase III trial is studying combination chemotherapy and radiation therapy given with AE-941 to see how well they work compared to combination chemotherapy and radiation therapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery

Key facts

Study ID

NCT00005838

Run by

National Cancer Institute (NCI)

People needed

756

Starts

2000-03-01

Last updated by the study team

2013-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed newly diagnosed, untreated, unresectable stage IIIA or stage IIIB non-small cell lung cancer
• Squamous cell carcinoma, adenocarcinoma, or large cell carcinoma of the lung
• Mixed tumors allowed if non-small cell elements identified
• Contralateral supraclavicular and/or scalene lymph node involvement allowed
• No disease extending into the cervical region
• At least 1 bidimensionally or unidimensionally measurable lesion
• No pleural effusion unless cytologically negative or too small to safely aspirate
• Not scheduled for curative cancer surgery
• Performance status - ECOG 0-1
• Absolute neutrophil count greater than 1,500/mm\^3
• Platelet count greater than 100,000/mm\^3
• Hematocrit greater than 30%
• SGOT or SGPT less than 1.5 times upper limit of normal
• Bilirubin normal
• Creatinine less than 1.5 mg/dL
• Creatinine clearance greater than 60 mL/min
• No other major medical or psychiatric illness that would preclude study participation or consent
• No medical condition that interferes with oral medication intake and/or absorption (gastrectomy or major intestinal resection)
• No grade 2 or greater peripheral neuropathy unless secondary to mechanical etiology
• No hypersensitivity to fish products
• No more than 10% weight loss within past 3 months
• No other malignancy within past 3 years except inactive carcinoma in situ of the cervix or nonmelanoma skin cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.