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

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

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Radiation Therapy Oncology Group
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel; Vinorelbine

Criteria

Inclusion Criteria:

• 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

• At least 30 days since prior chemotherapy

• See Disease Characteristics

• Recovered from prior major surgery

• At least 30 days since prior shark cartilage products

• No other concurrent investigational anticancer agents

• No other concurrent cartilage products

• No other concurrent investigational agents

• No concurrent amifostine or other radioprotectants

• No concurrent enrollment in other clinical trials