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

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 18 and over NCCAM, NCI MDA-ID-99303 NCCAM, NCI-T99-0046, NCT00005838, RTOG-0270

Objectives

1. 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).
2. Determine the progression-free survival, tumor response, tumor response duration, and metastasis-free survival of patients treated with these regimens.
3. 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:

• Not specified

Chemotherapy:

• At least 30 days since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

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:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

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

Overall survival every 3 months

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.

Lu 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

Charles Lu, MD, SM, Protocol chair		Ph: 713-792-6363; 800-392-1611 Email: clu@mdanderson.org

Radiation Therapy Oncology Group

Roy Herbst, MD, PhD, Protocol co-chair		Ph: 713-792-6363; 800-392-1611 Email: rherbst@mdanderson.org

Related Information

Featured trial article

Registry Information
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
Trial Start Date		2000-03-21
Trial Completion Date		2007-02-27
Registered in ClinicalTrials.gov		NCT00005838
Date Submitted to PDQ		2000-04-06
Information Last Verified		2006-02-15
NCI Grant/Contract Number		CA16672