NCT00042835

Brief Summary

Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and radiation therapy with combination chemotherapy may kill more tumor cells. Phase I trial to study the effectiveness of combining erlotinib and radiation therapy with combination chemotherapy in treating patients who have inoperable stage III non-small cell lung cancer

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

6.6 years

First QC Date

August 5, 2002

Last Update Submit

January 31, 2013

Conditions

Adenocarcinoma of the LungBronchoalveolar Cell Lung CancerLarge Cell Lung CancerSquamous Cell Lung CancerStage IIIA Non-small Cell Lung CancerStage IIIB Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • MTD defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0

    7 weeks

Secondary Outcomes (2)

  • Response assessed using RECIST

    Up to 8 weeks

  • Level of EGFR expression

    Up to 8 weeks

Study Arms (2)

Group I (cisplatin, etoposide, erlotinib, and docetaxel)

EXPERIMENTAL

Patients receive cisplatin IV over 2 hours on days 1, 8, 29, and 36; etoposide IV over 1 hour on days 1-5 and 29-33; and oral erlotinib once daily on days 1-49. Patients undergo concurrent radiotherapy 5 days a week for 7 weeks beginning on day 1. Patients receive consolidation therapy comprising docetaxel IV over 1 hour on days 50, 71, and 92. Some patients may also receive oral erlotinib once daily on days 50-112.

Drug: cisplatinDrug: etoposideDrug: erlotinib hydrochlorideRadiation: radiation therapyDrug: docetaxelOther: laboratory biomarker analysis

Group II (paclitaxel, carboplatin, and erlotinib

EXPERIMENTAL

Patients receive induction chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21. Patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 43, 50, 57, 64, 71, 78, and 85 and oral erlotinib once daily on days 43-91. Patients undergo radiotherapy concurrently with consolidation therapy 5 days a week for 7 weeks beginning on day 43.

Drug: erlotinib hydrochlorideRadiation: radiation therapyDrug: paclitaxelDrug: carboplatinOther: laboratory biomarker analysis

Interventions

cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Group I (cisplatin, etoposide, erlotinib, and docetaxel)
etoposideDRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213
Group I (cisplatin, etoposide, erlotinib, and docetaxel)
erlotinib hydrochlorideDRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774
Group I (cisplatin, etoposide, erlotinib, and docetaxel)Group II (paclitaxel, carboplatin, and erlotinib
radiation therapyRADIATION

Undergo radiotherapy

Also known as: irradiation, radiotherapy, therapy, radiation
Group I (cisplatin, etoposide, erlotinib, and docetaxel)Group II (paclitaxel, carboplatin, and erlotinib
docetaxelDRUG

Given IV

Also known as: RP 56976, Taxotere, TXT
Group I (cisplatin, etoposide, erlotinib, and docetaxel)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Group II (paclitaxel, carboplatin, and erlotinib
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Group II (paclitaxel, carboplatin, and erlotinib
laboratory biomarker analysisOTHER

Correlative studies

Group I (cisplatin, etoposide, erlotinib, and docetaxel)Group II (paclitaxel, carboplatin, and erlotinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed non-small cell lung cancer
  • Squamous cell carcinoma
  • Adenocarcinoma (including bronchoalveolar)
  • Large cell carcinoma (including giant and clear cell carcinomas)
  • Stage IIIA (T1 or T2, N2) or IIIB disease not amenable to resection or surgery
  • T3, N2 or T4, N0-N2 disease also allowed if based on the closeness to the carina, invasion of the mediastinum, or invasion of the chest wall
  • T3, N0-N1 disease allowed provided the disease is not amenable for surgical resection
  • No M1 disease
  • No disease invasion of a vertebral body
  • Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiotherapy boost field and there is no bone invasion
  • Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiotherapy boost field
  • Pleural effusion that is transudative, cytologically negative, and non-bloody allowed if the tumor can be encompassed in a reasonable field of radiotherapy
  • No exudative, bloody, or cytologically malignant effusions
  • Effusions present on CT scans but not on chest x-ray (CXR) and too small for thoracentesis are allowed
  • Measurable or evaluable disease
  • +47 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Adenocarcinoma of LungAdenocarcinoma, Bronchiolo-AlveolarCarcinoma, Non-Small-Cell Lung

Interventions

CisplatinEtoposideErlotinib HydrochlorideRadiotherapyRadiationDocetaxelPaclitaxelTaxesCarboplatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteCarcinoma, BronchogenicBronchial NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTherapeuticsPhysical PhenomenaTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsCoordination Complexes

Study Officials

  • Ann Mauer

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2002

First Posted

January 27, 2003

Study Start

May 1, 2002

Primary Completion

December 1, 2008

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

US(1)