Study of Tarceva and Targretin in Stage I-II Lung Cancer

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00125372
• Collaborator: Ligand Pharmaceuticals (Industry), Genentech, Inc. (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 56
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-small-cell Lung	Drug: erlotinib (Tarceva) and bexarotene (Targretin)	N/A

Detailed Description

Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erlotinib and Bexarotene Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.	Drug: erlotinib (Tarceva) and bexarotene (Targretin); Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy; Other Names: Tarceva Targretin

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Change in Expression Level of EGFR. [Baseline and 9 days]

2. Number of Participants With Change in Expression Level of Cyclin D1 [Baseline and 9 days]

3. Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR) [Baseline and 9 days]

Secondary Outcome Measures

1. Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels [At 9 days]

2. Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response [Baseline and 9 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Resectable stage I or II non-small-cell lung cancer

• Prior tissue biopsy (not cytology) available for research analysis

• Adequate hepatic and renal function

Exclusion Criteria:

• Prior chemotherapy or radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center
• Ligand Pharmaceuticals
• Genentech, Inc.

Investigators

• Principal Investigator: Konstantin H Dragnev, MD, Norris Cotton Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Konstantin Dragnev, Associate Professor of Medicine, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT00125372
• Other Study ID Numbers: D-0453
• First Posted: Aug 1, 2005
• Last Update Posted: Jan 8, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by Konstantin Dragnev, Associate Professor of Medicine, Dartmouth-Hitchcock Medical Center: tarceva; targretin; non-small cell lung cancer; carcinoma, non-small cell lung cancer; nsclc
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Erlotinib Hydrochloride; Bexarotene

Study Results

Participant Flow

Arm/Group Title	Erlotinib and Bexarotene
Arm/Group Description	Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Period Title: Overall Study
STARTED	12
COMPLETED	10
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Erlotinib and Bexarotene
Arm/Group Description	Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 80%
>=65 years	2 20%
Sex: Female, Male (Count of Participants)
Female	7 70%
Male	3 30%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	10 100%
Smoking status (Count of Participants)
Current	3 30%
Never	1 10%
Former	6 60%
Histology (Count of Participants)
Sqamous Cell carcinoma	1 10%
Adenocarcinoma	6 60%
Adenosquamous carcinoma	1 10%
Bronchioloalveolar carcinoma	1 10%
Basaloid carcinoma	1 10%
EGFR Status (Count of Participants)
Wild Type	8 80%
Mutant	1 10%
Not assessed	1 10%
KRAS Status (Count of Participants)
Wild type	4 40%
Mutant	5 50%
Not assessed	1 10%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Change in Expression Level of EGFR.
Time Frame	Baseline and 9 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erlotinib and Bexarotene
Arm/Group Description	Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Measure Participants	10
Reduction in EGFR expression	3 30%
No change	7 70%

2. Primary Outcome

Title	Number of Participants With Change in Expression Level of Cyclin D1
Time Frame	Baseline and 9 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erlotinib and Bexarotene
Arm/Group Description	Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Measure Participants	10
Reduction in Cyclin D1 expression	6 60%
No change	4 40%

3. Primary Outcome

Title	Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
Time Frame	Baseline and 9 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erlotinib and Bexarotene
Arm/Group Description	Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Measure Participants	10
Reduction in pEGFR expression	6 60%
No change	4 40%

4. Secondary Outcome

Title	Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels
Time Frame	At 9 days

Outcome Measure Data

Analysis Population Description

The testing necessary to determine the correlation documented in this outcome was not performed due to budget constraints.

Arm/Group Title	Erlotinib and Bexarotene
Arm/Group Description	Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Measure Participants	0

5. Secondary Outcome

Title	Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
Time Frame	Baseline and 9 days

Outcome Measure Data

Analysis Population Description

The numbers analyzed are represented in the rows by EGFR status at baseline. Eight participants had wild-type EGFR at baseline, one had a mutation at Exon 21, and one participant's EGFR status was not assessed at baseline. The total of all rows matches the overall number analyzed; 10.

Arm/Group Title	Erlotinib and Bexarotene
Arm/Group Description	Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Measure Participants	10
Therapeutic Response	4 40%
No Therepeutic Response	4 40%
Therapeutic Response	1 10%
No Therepeutic Response	0 0%
Therapeutic Response	0 0%
No Therepeutic Response	1 10%

Adverse Events

Time Frame	Adverse event data was collected for each patient at the start of study treatment until 4 weeks following surgical resection. The total time of adverse event collection over the course of the study from the first treated subject to the last treated patient's end-of-study visit was 4 years.
Arm/Group Title	Erlotinib and Bexarotene
Arm/Group Description	Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
All Cause Mortality
	Erlotinib and Bexarotene
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Erlotinib and Bexarotene
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Erlotinib and Bexarotene
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.