CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
carboplatin +2 moredrug
Likely dose
Sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks off, up to 1 yearAI-extracted
Key inclusion· 4
  • Histologically confirmed non-small cell lung cancer
  • Stage IIIB (locally advanced with malignant effusion) or Stage IV disease
  • No prior systemic therapy for NSCLC
  • Evidence of unidimensionally measurable disease
Key exclusion· 6
  • Prior systemic chemotherapy for lung cancer
  • History of or known brain metastases
  • NCI CTCAE Grade 3 hemorrhage within 4 weeks of study start
  • Evidence of hemoptysis within 4 weeks of study start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00113516
NCT00113516Phase 2Completed

Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

Pfizer·interventional·Posted Jun 9, 2005·Updated May 18, 2010

In Brief

A Phase 2 clinical trial evaluating carboplatin, paclitaxel, and 1 other intervention for Non-small Cell Lung Cancer. Completed, enrolled 84 participants across 31 sites in 3 countries.

Detailed Summary

The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 9, 2005
Enrollment StartSep 1, 2005
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 21.1 years ago

Interventions

carboplatindrug

AUC of 6 mg\*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.

paclitaxeldrug

175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.

sunitinibdrug

50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol).