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


Phase 3
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

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Trial Information

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


PRIMARY OBJECTIVES:

I. 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).

II. Determine the progression-free survival, tumor response, tumor response duration, and
metastasis-free survival of patients treated with these regimens.

III. 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Survival distributions will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted to illustrate the comparative survival experience of both groups over the entire study period.

Outcome Time Frame:

From randomization until date of death or last follow-up, assessed up to 7 years

Safety Issue:

No

Principal Investigator

Charles Lu

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02725

NCT ID:

NCT00005838

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Lung
  • Adenosquamous Cell Lung Cancer
  • Large Cell Lung Cancer
  • Squamous Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
M D Anderson Cancer Center Houston, Texas  77030