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RATIONALE: 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.
PURPOSE: 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.
- Determine the overall survival of patients with unresectable stage IIIA or IIIB non-small cell lung cancer treated with induction platinum-based chemotherapy and radiotherapy with or without AE-941 (Neovastat).
- Determine the progression-free survival, tumor response, tumor response duration, and metastasis-free survival of patients treated with these regimens.
- Determine the tolerability of this regimen in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to stage (IIIA vs IIIB), type of platinum-based induction chemotherapy to be received (cisplatin and vinorelbine vs carboplatin and paclitaxel), and gender. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral AE-941 (Neovastat) twice daily beginning on day 1 or within 10 days of initiation of chemotherapy.
- Arm II: Patients receive oral placebo twice daily beginning on day 1 or within 10 days of initiation of chemotherapy.
All patients receive induction chemotherapy with 1 of the following platinum-based regimens:
- Cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71, and 78
- Carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57, 64, 71, 78, and 85 All patients receive radiotherapy beginning on day 50 for 6 weeks.
Treatment in both arms continues in the absence of unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 756 patients (378 per treatment arm) will be accrued for this study within 36 months.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment
carboplatin, cisplatin, paclitaxel, shark cartilage extract AE-941, vinorelbine ditartrate, radiation therapy
Helen and Harry Gray Cancer Center at Hartford Hospital
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:57:38-0400
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An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.
An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.
A dehydrated extract of thyroid glands. After the removal of fat and connective tissue, the extract is dried or lyophilized to yield a yellowish to buff-colored amorphous powder containing 0.17-0.23% of iodine.
A type of CARTILAGE characterized by a homogenous amorphous matrix containing predominately TYPE II COLLAGEN and ground substance. Hyaline cartilage is found in ARTICULAR CARTILAGE; LARYNGEAL CARTILAGES; and the NASAL SEPTUM.
A type of CARTILAGE whose matrix contains ELASTIC FIBERS and elastic lamellae, in addition to the normal components of HYALINE CARTILAGE matrix. Elastic cartilage is found in the EXTERNAL EAR; EUSTACHIAN TUBE; EPIGLOTTIS; and LARYNX.
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