CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Gemcitabine +3 moredrug
Likely dose
Gemcitabine and carboplatin (induction); weekly carboplatin and paclitaxel concurrent with thoracic radiation starting day 57AI-extracted
Key inclusion· 7
  • ✓Histologically confirmed unresectable non-small cell carcinoma of the lung (adenocarcinoma, squamous cell carcinoma, or anaplastic large cell carcinoma)
  • ✓Stage IIIA (if unresectable) or Stage IIIB without significant pleural effusion
  • ✓No evidence of distant metastasis
  • ✓Measurable disease by RECIST criteria with baseline measurements within 4 weeks of registration
Key exclusion· 6
  • ✕Small cell carcinoma component on histology
  • ✕Preexisting clinically significant peripheral neuropathy
  • ✕Prior systemic chemotherapy or thoracic radiotherapy
  • ✕Significant pleural effusion (present on CT only, or reaccumulates after thoracentesis, or cytologically positive)

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

Search/NCT00226590
NCT00226590Phase 2Completed
CompareCT.gov

Phase II Trial of Induction Gemcitabine and Carboplatin Followed by Paclitaxel and Carboplatin With Concurrent Thoracic Radiation for Patients With Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Sep 27, 2005·Updated Mar 23, 2017

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Carboplatin, and 2 other interventions for Lung Cancer. Completed, enrolled 39 participants across 1 site.

Detailed Summary

This is a single institution Phase II study for patients with unresectable Stage IIIA and IIIB non-small cell lung cancer. The treatment started with 2 cycles of gemcitabine and carboplatin followed by concurrent chemotherapy with radiation. The chemoradiation included using paclitaxel and carboplatin with daily thoracic radiation to a total dose of 74 Gy. Response rate was determined following the chemotherapy with gemcitabine and carboplatin and evaluated again after the chemoradiation. Treatment toxicities were also assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2005
Enrollment StartApr 1, 2003
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.8 years ago

Interventions

Gemcitabinedrug

Induction Chemotherapy.

Carboplatindrug

Induction Chemotherapy. Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.

Paclitaxeldrug

Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.

Radiationprocedure

Radiation Therapy will begin on day 57 if there has been adequate hematologic recovery from Induction Chemotherapy.