Back to resultsCombination 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
Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Lung
Eligibility 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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (shark cartilage extract AE-941)
Arm II (placebo)
Patients receive oral AE-941 (Neovastat) 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 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.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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