Know Cancer

or
forgot password

A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically
positive pleural or pericardial effusion or Stage IV.

- No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment
of NSCLC.

- ECOG Performance Status of 2 .

- Patients must be at least 3 weeks since major surgery. Patients must be at least 1
week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy.

- Patients must have measurable disease, defined as lesions that can be accurately
measured in at least 1 dimension (longest diameter to be recorded) as greater than or
equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT
scan.

Exclusion Criteria:

- Any prior radiation therapy to the thoracic area.

- Active and ongoing systemic infection.

- Prior radiation to greater than 25% of the bone marrow.

- ECOG PS other than 2

- Patients with a known hypersensitivity to gemcitabine and carboplatin.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

9297

NCT ID:

NCT00190710

Start Date:

March 2004

Completion Date:

August 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bedford, Texas  76022