NCT00125359

Brief Summary

The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer. Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 13, 2018

Completed
Last Updated

January 8, 2019

Status Verified

December 1, 2018

Enrollment Period

8.6 years

First QC Date

July 29, 2005

Results QC Date

August 23, 2018

Last Update Submit

December 14, 2018

Conditions

Carcinoma, Non-small-cell Lung

Keywords

tarcevatargretinnon-small cell lung cancerCarcinoma, non-small cell lung cancerNSCLC

Outcome Measures

Primary Outcomes (1)

  • Radiographic Response Rates

    Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Correlation of Early PET Responses With Objective Radiographic Responses.

    Through study completion, an average of 1 year

  • Progression-free Survival and Overall Survival

    Through study completion, an average of 1 year

  • Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses.

    Through study completion, an average of 1 year

Study Arms (1)

1

EXPERIMENTAL

All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.

Drug: erlotinib and bexarotene

Interventions

erlotinib and bexaroteneDRUG

Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.

1

Eligibility Criteria

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

You may qualify if:

  • Advanced NSCLC
  • Prior chemotherapy or radiotherapy is allowed.

You may not qualify if:

  • Hepatic or renal dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma

Interventions

Erlotinib HydrochlorideBexarotene

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Konstantin Dragnev, MD
Organization
Dartmouth-Hitchcock Medical Center
Konstantin.H.Dragnev@Hitchcock.org
603-650-6344

Study Officials

  • Konstantin H Dragnev, MD

    Norris Cotton Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 1, 2005

Study Start

August 1, 2005

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 8, 2019

Results First Posted

November 13, 2018

Record last verified: 2018-12

Locations

US(2)