CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Carboplatin AUC 6.0 intravenously on day 5; Gemcitabine 1000 mg/m² intravenously on days 5 and 12; Dexamethasone 16 mg bid for 4 days prior to each chemotherapy cycleAI-extracted
Key inclusion· 7
  • Untreated stage IIIB NSCLC with pleural effusion
  • Untreated stage IV NSCLC
  • Recurrent after surgery if no prior radiation, chemotherapy, or immunotherapy (except palliative radiotherapy)
  • Age ≥18 years
Key exclusion· 12
  • Prior cancer history unless curative treatment completed ≥5 years before entry
  • Prior chemotherapy or immunotherapy for NSCLC (except brain/bone/lung radiation for palliative purposes)
  • Prior radiation to >25% of bone marrow for any previous cancer
  • Uncontrolled intercurrent illness

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

Search/NCT00247416
NCT00247416Phase 2Completed

Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer

Susanne Arnold·interventional·Posted Nov 1, 2005·Updated Mar 7, 2014

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Dexamethasone, and 1 other intervention for Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer. Completed, enrolled 60 participants across 7 sites.

Detailed Summary

The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer. This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 1, 2005
Enrollment StartAug 1, 2005
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 20.7 years ago

Interventions

Gemcitabinedrug

Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.

Dexamethasonedrug

16 mg bid for 4 days prior to each chemotherapy start.

Carboplatindrug

AUC 6.0 intravenously over 30 minutes on day 5.