CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
carboplatin +4 moredrug
Likely dose
Paclitaxel 50 mg/m² weekly x 3 weeks; Carboplatin AUC2 weekly x 3 weeks; Erlotinib daily; Radiation 150 cGy bidAI-extracted
Key inclusion· 6
  • Histologically or cytologically confirmed non-small cell lung cancer
  • Surgically determined stage IIIA or IIIB disease
  • Measurable and evaluable disease
  • Patients with N3 or T4 status must be evaluated and deemed potentially resectable after induction chemotherapy and radiation therapy
Key exclusion· 8
  • No malignant pleural effusion except for effusion visible only on CT scan and deemed too small to tap
  • No pericardial effusion
  • No small or mixed small cell/non-small cell lung cancer
  • No massive lesions requiring radiation to the entire lung

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

Search/NCT00278148
NCT00278148Phase 2Completed

A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) With Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy With OSI-774 for Stage III Non-Small Cell Lung Cancer

Nathan Pennell, MD, PhD·interventional·Posted Jan 18, 2006·Updated Jul 20, 2020

In Brief

A Phase 2 clinical trial evaluating carboplatin, Erlotinib, and 3 other interventions for Lung Cancer. Completed, enrolled 32 participants across 1 site.

Detailed Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib, paclitaxel, and carboplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the best dose of erlotinib and the side effects of erlotinib, paclitaxel, and carboplatin when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2006
Enrollment StartOct 1, 2005
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.5 years ago

Interventions

carboplatindrug

AUC2 weekly x 3 weeks

Erlotinibdrug

Daily

paclitaxeldrug

50mg/m2/weekly x 3 weeks

conventional surgeryprocedure

conventional surgery

radiation therapyradiation

150 cGy bid