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Phase III Randomized Study of Induction Platinum-Based Chemotherapy and Radiotherapy With or Without AE-941 (Neovastat) in Patients With Unresectable Stage IIIA or IIIB Non-Small Cell Lung Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Published Results Trial Contact Information Related Information Registry Information
Alternate Title
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
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Treatment
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Completed
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18 and over
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NCCAM, NCI
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MDA-ID-99303 NCCAM, NCI-T99-0046, NCT00005838, RTOG-0270
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Objectives - 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.
Entry Criteria Disease Characteristics:
- 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
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: - At least 30 days since prior chemotherapy
Endocrine therapy: Radiotherapy: Surgery: - See Disease Characteristics
- Recovered from prior major surgery
Other: - 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
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - Absolute neutrophil count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
- Hematocrit greater than 30%
Hepatic: - SGOT or SGPT less than 1.5 times upper limit of
normal
- Bilirubin normal
Renal: - Creatinine less than 1.5 mg/dL
OR - Creatinine clearance greater than 60 mL/min
Other: - 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
Expected Enrollment A total of 756 patients (378 per treatment arm) will be accrued for this study
within 36 months. Outcomes Primary Outcome(s)Overall survival every 3 months
Secondary Outcome(s)Progression-free survival every 3 months
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. Published ResultsLu C, Lee JJ, Komaki R, et al.: A phase III study of AE-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99-0046, RTOG 02-70, MDA 99-303). [Abstract] J Clin Oncol 25 (Suppl 18): A-7527, 391s, 2007. Lu C, Komaki R, Herbst RS, et al.: A phase III study of AE-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non-small cell lung cancer (NSCLC) (NCI T99-0046, RTOG 02-70, MDA 99-303): an interim report of toxicity and response. [Abstract] J Clin Oncol 23 (Suppl 16): A-7144, 656s, 2005.
Trial Contact Information
Trial Lead Organizations M. D. Anderson Cancer Center at University of Texas ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | Charles Lu, MD, SM, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) |
Radiation Therapy Oncology Group ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | Roy Herbst, MD, PhD, Protocol co-chair | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) |
Related Information Featured trial article
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) for Locally Advanced Unresectable Non-Small Cell Lung Cancer | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2000-03-21 | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2007-02-27 | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00005838 | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2000-04-06 | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2006-02-15 | ![](https://webarchive.library.unt.edu/eot2008/20081013142726im_/http://www.cancer.gov/images/spacer.gif) | NCI Grant/Contract Number | | CA16672 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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