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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00924209
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    1250 mg/m\^2 dose for two doses on days 1 and 8
  • Cisplatin — DRUG
    80 mg/m\^2 on day 1
  • Bevacizumab — DRUG
    7.5 mg/m\^2 on day 1 every 21 days for first two cycles only
  • Surgery — PROCEDURE
    thoracotomy with lobectomy/pneumonectomy and mediastinal lymph node dissection 4-6 weeks post completion of last cycle of cisplatin
  • Etoposide — DRUG
    100 mg/m\^2 intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles.

Study Details

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.

Key Dates

First listed
Jun 18, 2009
Start date
Mar 31, 2009
Status verified
Nov 2018
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stage IIIA lung cancer patients
    Non-squamous cell non small cell lung cancer treated with 1250 mg/m\^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m\^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m\^2 intravenous, and 100 mg/m\^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles.

Primary Outcome Measure

Rate of Pathologic Complete Response [ Time Frame: 25 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

Related Studies