A Phase II Study of Neo-Adjuvant Gemcitabine, Cisplatin and Bevacizumab in Stage IIIA (N2) Non-Squamous Cell Non-Small Cell Lung Cancer

Summary

Background:

* Surgical resection is the treatment of choice for patients with lung cancer, and cure after resection generally depends on whether lymph nodes are involved. A patient with Stage IIIA (N2) lung cancer has cancer in the lymph nodes involving the center of the chest (mediastinum).
* Studies have shown that surgery alone as a treatment for Stage IIIA (N2) lung cancer is not as effective as chemotherapy followed by surgery.
* Giving chemotherapy upfront may prevent the spread of Stage IIIA (N2) lung cancer tumors, and may shrink the tumors to allow adequate surgery to be performed. It is also thought that chemotherapy is usually better tolerated before major surgery than after, so higher doses can be given.

Objectives:

* To determine the effectiveness of the combination of three anti-cancer drugs (gemcitabine, cisplatin, and bevacizumab) given before surgery.
* To find out what effects this drug combination may have on the patient and the cancer.
* To determine if the combination of all three drugs given prior to surgery is more effective and as safe, safer, or less safe than other drug combinations given before surgery.

Eligibility:

* Patients with Stage IIIA (N2) lung cancer who have not had chemotherapy, radiation, or surgery to treat the cancer.

Design:

* Evaluations before the treatment period to determine eligibility:
* Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.
* Tests to evaluate heart and lung function, such as an echocardiogram.
* Blood and urine tests.
* Disease evaluation with computed tomography (CT), chest X-ray, positron emission tomography (PET) scans, and bronchoscopy/mediastinoscopy (examinations of the inside of the chest and lungs).
* Treatment with intravenous gemcitabine, cisplatin, and bevacizumab for three 21-day cycles.
* Cycles 1 and 2 - Gemcitabine on day 1 and day 8, cisplatin on day 1, bevacizumab on day 1.
* Cycle 3 - Gemcitabine on day 1 and day 8, cisplatin on day 1 (no bevacizumab).
* Physical examinations and tests will be conducted throughout each cycle.
* Surgery will take place 4 to 6 weeks after the last cycle if heart and lung functions are satisfactory and if the cancer remains stable.
* Chemotherapy (four 21-day cycles of cisplatin and etoposide treatments), further evaluations and examinations, and followup studies will take place 4 to 8 weeks after the surgery.

Conditions

• NSCLC
• Stage IIIA (N2)

Interventions

DRUG

Gemcitabine

1250 mg/m\^2 dose for two doses on days 1 and 8

DRUG

Cisplatin

80 mg/m\^2 on day 1

DRUG

Bevacizumab

7.5 mg/m\^2 on day 1 every 21 days for first two cycles only

PROCEDURE

Surgery

thoracotomy with lobectomy/pneumonectomy and mediastinal lymph node dissection 4-6 weeks post completion of last cycle of cisplatin

DRUG

Etoposide

100 mg/m\^2 intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Giuseppe Giaccone, M.D. · National Cancer Institute, National Institutes of Health

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2011-09-30

Completion

2011-09-30

FDA Drug

Yes

Countries

• United States
• Croatia

Study Locations