Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial

ALIMTA Plus Gemcitabine as Front-line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Phase II Clinical Trial

Sponsoren

Hauptsponsor: Eli Lilly and Company

Quelle Eli Lilly and Company
Kurze Zusammenfassung

The purposes of this study are to determine:

1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.

2. Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.

3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.

4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.

Gesamtstatus Completed
Anfangsdatum December 2002
Fertigstellungstermin September 2006
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.
Sekundäres Ergebnis
Messen Zeitfenster
To assess time to objective tumor response for responding patients
To assess duration of response for responding patients
To assess time to treatment failure for patients
To assess progression free survival of patients
To assess time to progressive disease for patients
To assess survival time for patients
To characterize the toxicities of gemcitabine plus pemetrexed in this patient population
Einschreibung 48
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Pemetrexed

Interventionsart: Drug

Interventionsname: Gemcitabine

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy.

- Have received no prior chemotherapy for Non-Small Cell Lung Cancer.

- Have at least one measurable lesion.

- Have an adequate performance status.

- Sign an informed consent.

Exclusion Criteria:

- A female who is pregnant or breastfeeding.

- Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.

- Treatment with radiation therapy within the last 4 weeks.

- Brain metastasis that is uncontrolled.

- Active infection or other serious condition.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
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) Study Director Eli Lilly and Company
Ort
Einrichtung:
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Palo Alto, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Columbia, Missouri, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kansas City, Missouri, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Great Falls, Montana, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seattle, Washington, United States
Standort Länder

United States

Überprüfungsdatum

December 2010

Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov